The podcast from statisticians for statisticians to have a bigger impact at work. This podcast is set up in association with PSI – Promoting Statistical Insight. This podcast helps you to grow your leadership skills, learn about ongoing discussions in the scientific community, build you knowledge about the health sector and be more efficient at work. This podcast helps statisticians at all levels with and without management experience. It is targeted towards the health, but lots of topics will be important for the wider data scientists community.
The podcast The Effective Statistician – in association with PSI is created by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry. The podcast and the artwork on this page are embedded on this page using the public podcast feed (RSS).
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Learn, Do, Reflect, and Start Again! How to Become a Better Leader
Becoming a better leader starts with taking intentional steps to learn, apply, and reflect on your actions.
This episode offers practical insights and strategies to help you grow as a leader and create meaningful impact in your organization. Don’t miss the chance to transform your approach to leadership—listen now to discover how small, consistent efforts can lead to big results.
If you find this episode valuable, share it with your friends and colleagues so they can benefit too. Together, we can all become more effective leaders!
Planning for 2025 doesn’t have to be overwhelming—it can be a powerful exercise in aligning your goals with your ideal lifestyle and long-term aspirations. In this episode, Alun Bedding provides actionable strategies and thoughtful insights to help you approach the year ahead with clarity and purpose. Whether you’re aiming to elevate your career, find balance, or simply refine your approach to goal-setting, this episode is packed with ideas you won’t want to miss.
So, listen now and take the first step toward making 2025 your most impactful year yet. And if you found this episode valuable, don’t keep it to yourself—share it with friends and colleagues who could benefit from these transformative strategies!
Early Development and The Dose Selection in the Immune-oncology
Understanding dose selection in immune-oncology is crucial for developing safer and more effective treatments, and statisticians play a central role in driving these decisions.
In this episode, Teppo shares practical insights into overcoming the limitations of traditional methods and adopting more flexible approaches like the BOIN design.
If you want to stay ahead in oncology research and learn how to balance safety, efficacy, and practical challenges in dose optimization, this episode is a must-listen!
Sharpening the saw is about investing in yourself to stay balanced, proactive, and effective in every aspect of your work and life.
In this episode, Alun shares actionable insights and strategies that can help statisticians like you thrive. Don’t miss this opportunity to learn how continuous renewal can transform your productivity and mindset. Tune in now and take the first step toward becoming a more effective statistician.
If you found this episode valuable, share it with your friends and colleagues who could benefit from these insights, and let’s spread the power of sharpening the saw together!
Why is it important to measure exposure to digital health interventions and how to tackle the challenge
Mental health focus: Apps, virtual reality, stigma reduction, barriers to care.
Cluster analysis: Grouping users, multidimensional engagement measures, case studies.
Comparison to marketing: Engagement metrics, optimization, dynamic updates.
Risks and opportunities: Growing field, need for early research, potential harm.
Role of statisticians: Methodology, decentralized trials, PROs, future research.
Call to action: Explore the field, learn, engage with associations.
Digital health interventions are transforming healthcare, offering exciting opportunities and posing new challenges for statisticians and researchers alike. From defining engagement to tackling complex data with innovative methods, this field has much to explore.
I hope this episode inspires you to dive deeper into this growing area and consider how you can contribute to its evolution. If you found this discussion valuable, I encourage you to listen to the full episode and share it with your friends and colleagues who might benefit from these insights.
Why Do Clinical Trials Impact the Climate Heavily and What We Can Do About It?
Clinical trials play a vital role in advancing healthcare, but their environmental impact cannot be ignored. By rethinking how we design and operate trials, we can reduce carbon emissions, streamline processes, and contribute to a greener future. Whether it’s embracing decentralized trials, simplifying study designs, or engaging in sustainability initiatives, we all have a part to play.
If this episode inspired you, share it with your friends and colleagues. Let’s spark conversations about making clinical research more sustainable and work together to create positive change. Don’t forget to listen, reflect, and take action—every step counts!
Introduction to Dealing with Non-proportional Hazards
Non-Proportional Hazards: Understanding when and why the proportional hazards assumption fails.
Hazard Functions: Differences between survival functions and hazard functions; interpreting dynamics over time.
Data Visualization: Importance of visualizing hazard functions alongside Kaplan-Meier curves.
Clinical Context: Collaborating with clinicians to understand treatment effects and disease dynamics.
Effect Quantification: Exploring alternatives to hazard ratios when proportionality doesn’t hold.
Trial Design: Challenges in designing studies with non-proportional hazards and strategies to address them.
Simplification Risks: Avoiding oversimplifications like responder analysis or arbitrary sample size increases.
Stakeholder Communication: Explaining complex survival data effectively to non-statisticians.
Regulatory Considerations: Balancing valid hypothesis testing with meaningful effect quantification.
Actionable Insights: Practical steps for statisticians to improve survival analysis and trial design.
Dealing with non-proportional hazards is a complex but critical aspect of survival analysis, and understanding it can make a significant difference in your work. In this episode, Kaspar and I covered everything from hazard functions and survival curves to practical strategies for trial design and effect quantification. If you found these insights valuable, don’t keep them to yourself!
Share this episode with your friends and colleagues who work with survival analysis or clinical trials. And if you haven’t already, make sure to subscribe so you never miss an episode of The Effective Statistician. Let’s work together to elevate the impact of statistics in healthcare!
How Real Leaders Help Their People Grow Professionally and As a Person
Leadership: Building trust, inspiring growth, and prioritizing collaboration.
Mentorship: Klaus guiding Aziza to discover her passion for statistics.
Professional Growth: Empowering team members to learn and succeed.
Authenticity: Honest communication and standing by data-driven insights.
Collaboration: Creating win-win situations for individuals and the organization.
Trust-Building: Establishing credibility through support and training.
Empowerment: Teaching others to leverage tools and make informed decisions.
Sustainable Value: Creating systems that deliver results even in your absence.
Continuous Learning: Both leaders and team members growing together.
Personal Growth: Developing not just careers, but individuals as a whole.
This episode highlights the transformative power of authentic leadership, trust, and mentorship in driving both personal and professional growth. Aziza and Klaus show us how fostering collaboration and empowering others can create lasting value for individuals and organizations alike. Their story is filled with practical lessons and inspiring insights that can help you on your own journey as a statistician, leader, or team member.
Statisticians' Role: Essential contributions in planning and analysis
Guest Background: Oscar’s expertise in academia, med tech, biopharma, Humira development
Clinical Development: Phases from trials to commercialization
Rare Disease Focus: Hemophilia A, spinal muscular atrophy
Challenges & Opportunities: Unique clinical and statistical challenges
Future of Medicine: Insights into advancements in gene therapy
Oscar’s expertise sheds light on the unique challenges and groundbreaking possibilities in this field, highlighting the critical role that statisticians and data scientists play in advancing these therapies.
If you found this episode insightful, I encourage you to listen in full and share it with colleagues, friends, or anyone interested in the future of healthcare. Let’s spread the word on how statistical expertise is driving the next frontier in medicine—tune in, learn, and pass it on!
Interview with Avery McIntosh and Oleksandr Sverdlov
Key points:
Gene Therapy Potential
Role of Statisticians
Guest Experts Overview
Challenges
Statistical Innovation
Current Impact
Future Outlook
Audience Insight
Podcast Goals
In this episode, we dive deep into the science, the ethical hurdles, and the innovative statistical methods that make gene therapy possible. I encourage you to tune in and gain insights from our expert guests, Avery and Alex, as they share their experiences and perspectives on navigating this complex field.
If you find this episode valuable, please share it with colleagues, friends, and anyone interested in the future of medicine and data science. Let’s spread the knowledge and excitement around these life-changing advancements!
Cross-functional Collaboration: clinical, commercial, regulatory teams
Big Pharma vs. Startups: differences in resources, risk, investor expectations
Adaptive Design: flexibility in clinical phases, risk management
Regulatory Engagement: early involvement of FDA, EMA for approvals
Competitor Landscape: use of competitive intelligence for CDP design
Cost & Timeline Estimation: sample size, Gantt chart for budgeting
Together, we explore how to balance scientific rigor with business goals, collaborate across teams, and navigate the regulatory landscape to bring new therapies to life. Carrie shares practical advice and insights that can help anyone involved in drug development make a real impact.
Don’t miss this conversation—listen to the full episode, and if you find it valuable, share it with friends and colleagues who are passionate about advancing healthcare.
The Most Important Things You Need to Know About AI And ML
Large Language Models (LLMs): Role in transforming work processes, especially in AI and machine learning.
Practical Applications: Document retrieval, data exploration, code refinement.
Human Oversight: Importance of keeping human input in AI-assisted processes.
Communication: AI's potential to improve team communication and collaboration.
Validation Challenges: Ensuring accuracy and reliability of AI models.
Pharmaceutical Research: Use of LLMs in clinical trials, eligibility criteria, and patient data analysis.
AI Efficiency: How LLMs streamline workflows and reduce repetitive tasks.
Future of AI: Evolving capabilities of LLMs and the need to stay ahead in the field.
This episode reveals how large language models (LLMs) are transforming industries like pharmaceutical research and statistics. Pietro shares practical applications and emphasizes the need for human oversight, showcasing how AI is reshaping the way we work.
If you want to stay ahead in this rapidly evolving AI field, listen to this episode today! Be sure to share the episode link with colleagues and friends who can benefit from learning how AI can boost efficiency and collaboration. Tune in now!
Can Statisticians Contribute to Moving Out of The Statistics Function?
Expanding Careers: Statisticians moving beyond traditional statistics roles.
Transferable Skills: Data interpretation, strategic thinking, communication.
Career Transition: Swarna’s journey from statistician to strategic roles.
Broader Impact: Using statistical skills in non-technical positions.
Practical Advice: How statisticians can leverage their expertise.
Opportunities: New career paths and roles outside statistics.
Actionable Insights: Steps for statisticians to broaden their horizons.
In this episode, Swarna’s journey shows how statisticians can successfully move beyond the traditional boundaries of their roles and make a broader impact in various industries. If you're looking to take your skills to the next level and explore new career opportunities, this episode is full of valuable insights and practical advice.
Taina shares invaluable tips on getting started with Notion and highlights its potential to replace multiple tools while simplifying your personal and professional life.
Don’t miss out—tune in to the episode now and discover how you can start using Notion effectively. And if you found this episode helpful, be sure to share it with your colleagues and friends who could benefit from optimizing their productivity!
Statisticians and software engineering: Learning from software engineering practices to improve statistical work.
Daniel Sabanés Bové career path: Transition from biostatistician at Roche to data scientist at Google, and return to healthcare.
Software engineering principles: Importance of clean coding, automation, and collaborative development.
Coding in the pharma industry: How tech practices can enhance pharmaceutical statistical work.
Open-source tools: Utilizing tools like Git and automation workflows to improve efficiency.
Automation: Streamlining repetitive tasks to focus on value-adding work.
RCONIS: Daniel’s new consulting venture combining statistics and software engineering.
Daniel shows how software engineering principles can transform the way statisticians work, offering practical tips to improve coding skills and workflow efficiency. If you're looking to boost your productivity, adopt better coding habits, or learn more about the intersection of tech and pharma, this conversation is full of valuable insights.
Listen to the full episode now, and if you find it helpful, share it with your friends and colleagues who can benefit from these ideas. Let’s work together to improve and innovate!
Predictive Models: Forecast future outcomes based on historical data.
Model Building: Process of analyzing data, training, and testing models.
Validation: Ensures model reliability and accuracy.
Healthcare Applications: Use in survival rates, treatment responses.
Technical Discussion: Pruning models, interpretability, data considerations.
Tools: Use of R, Python, SAS for building predictive models.
Collaboration: Importance of interdisciplinary work, combining traditional statistics with AI/ML techniques.
Chantelle shares valuable insights into building, testing, and validating these models, showing just how powerful and essential they are.
If you found this discussion insightful, listen to the full episode to dive deeper into the technical details and practical applications of predictive modeling. And if you know others who would benefit from this knowledge, share the episode with them. Let’s spread these valuable insights together!
How AI Can Help Us with Our Day-to-day Work! Experiences with Copilot
As AI continues to revolutionize the way we work, tools like GitHub Copilot offer incredible opportunities to enhance productivity, simplify complex tasks, and accelerate learning. In this episode, Paolo and I dive into the practical applications of Copilot in our day-to-day work, sharing insights that can benefit statisticians and data scientists alike. Don’t miss out on this valuable discussion!
Tune in to the episode now, and if you find it helpful, be sure to share it with your friends and colleagues who could also benefit from AI tools like Copilot. Let's spread the knowledge and make work easier for everyone!
P.S. Don’t miss out on our upcoming Effective Statistician Online Conference: Fall 2024 – Transforming Healthcare!
Join us this November for an exciting opportunity to unlock the future of medical data with a special focus on RCT vs RWE, AI, and EU HTA. Whether you're looking for free access to keynotes and panel discussions or want to dive deeper with premium workshops on topics like Machine Learning, Data Visualization, and Personal Productivity—there’s something for everyone. Secure your spot now and connect with over 800 professionals from the healthcare industry! Mark your calendars: Nov 7-8 & Nov 11-12, 2024.
Learn how to transform your presentation skills and approach public speaking with confidence and ease. By focusing on your audience, practicing regularly, mastering your setup, and using your voice and gestures effectively, you deliver presentations like a pro.
Ready to take your skills to the next level? Listen now to get all the insights and tips! If you find this helpful, share this episode with your friends and colleagues who can also benefit from these strategies. Let’s all become better, more effective presenters together!
Last call for abstract submissions! You can participate in the Fall Conference 2024 for free by submitting an abstract for an 18-minute presentation or a poster. It’s a great chance to present and reuse content relevant to our community of statisticians, data scientists, and programmers in healthcare.
**📅 Deadline for abstracts: September 15
**📧 Submit to: [email protected]
And if presenting isn’t for you, don’t miss out—register now to lock in your early bird price!
The Best Learnings From One of The Most Influential Statisticians
Role of Luck: Influence of luck in career development.
Humility: Importance of staying humble in professional growth.
Continuous Learning: Emphasis on lifelong learning and adapting.
Career Decisions: Pivotal choices that shaped Stephen Zenn’s career.
Insights: Valuable lessons from decades of experience in statistics.
Influence: Stephen Zenn’s impact on the field of statistics.
Inspiration: Guidance for statisticians at all career stages.
As we conclude this insightful episode, Stephen’s reflections remind us to embrace both luck and continuous learning in our careers. His experiences offer valuable lessons that can resonate with statisticians and professionals alike. I encourage you to listen to the full episode to dive deeper into these ideas and draw inspiration for your own journey.
If you found this conversation valuable, share it with your colleagues and friends. Let’s spread the wisdom and keep the conversation going on how we can all grow and succeed in our careers.
In this episode, I cover essential tips for crafting slides that truly engage and enhance your presentations. By focusing on clarity, visual appeal, and storytelling, you can transform your slides into powerful tools that captivate your audience.
Don’t let your slides become a distraction—make them work for you! Tune in to the full episode to dive deeper into these strategies, and be sure to share it with friends and colleagues who also want to improve their presentation skills. Together, let’s elevate the way we communicate data and ideas!
AI in Clinical Research: Exploring the impact of artificial intelligence on clinical research and development.
Francois’ Experience: Insights from Francois, a seasoned expert with nearly 30 years in the pharmaceutical industry.
Transition to AI: Francois’ journey from traditional statistical methods to AI and machine learning applications.
Digital Twins: Discussion on the role of AI in creating digital twins for predicting patient outcomes.
Data Integration: How AI facilitates the integration of structured and unstructured data in clinical studies.
Statisticians and AI: The potential for statisticians to leverage AI to drive innovation in healthcare.
Future Opportunities: The growing importance of AI in shaping the future of clinical research.
AI as a Trend: Understanding why AI is more than just a passing trend in the industry.
AI transforms clinical development and offers immense potential, especially for statisticians aiming to make a significant impact in healthcare. Francois shares valuable insights on how AI enhances our work and shapes the future of clinical research.
If these possibilities excite you, listen to this episode. Share it with your colleagues and anyone interested in the convergence of AI and clinical research. Let’s spread the word and inspire others to explore how AI can revolutionize our field.
Resonance: What makes a presentation resonate with the audience?
Memorability: Turning a simple delivery into something unforgettable.
Ethos: Establishing credibility and trust with your audience.
Logos: Presenting logical arguments, data, and evidence.
Pathos: Creating an emotional connection with the audience.
Mastery: How mastering ethos, logos, and pathos enhances presentations.
Influence: Boosting your impact and influence as a statistician.
Conference: Submitting an abstract for the Effective Statistician Conference.
Mastering ethos, logos, and pathos will significantly elevate your presentations and boost your impact as a statistician. These timeless principles enhance your communication and help you connect more deeply with your audience.
Listen to this episode to dive deeper into these strategies and start applying them in your own presentations. If you find this episode valuable, share it with your friends and colleagues—let’s spread the knowledge and help each other become more effective communicators.
Tune in now and take your presentations to the next level!
And don’t miss the chance to submit your abstract for the upcoming Effective Statistician Fall Conference 2024!
Key points:
Biostatistics and IT Intersection: Exploring the relationship between biostatistics and IT.
Evolution of Technology: Shift from mainframes and standalone PCs to cloud computing.
Role of IT: Importance of IT in supporting statistical practices.
Hardware Requirements: Necessary hardware and software for efficient statistical work.
Data Security: Ensuring secure data handling and compliance with regulations.
Statistical Software: Discussion of tools like SAS, R, and Python.
Collaboration: Importance of effective communication between statisticians and IT professionals.
Challenges: Addressing common issues and misconceptions in the biostatistics-IT interface.
Leadership and Communication: Building trust and understanding between teams.
This episode offers a deep dive into the crucial relationship between biostatistics and IT, packed with practical insights and expert advice from Pablo’s extensive experience. Whether you’re navigating the technical challenges of your role or looking to improve collaboration with IT professionals, this discussion provides valuable takeaways that can elevate your work.
Don’t miss out on this opportunity to enhance your understanding—listen to the full episode now. And if you found it helpful, be sure to share it with your friends and colleagues who might benefit from these insights. Together, we can all become more effective statisticians.
5 Questions to Ask Yourself Before Opening PowerPoint
By asking yourself these five essential questions before you even open PowerPoint, you can create presentations that not only inform but also inspire action. Whether you’re aiming to influence key decision-makers or simply communicate more effectively, this episode provides the tools you need.
Don’t miss out—listen now, and be sure to share this episode with your friends and colleagues who could also benefit from mastering these techniques. Together, we can all become more effective communicators.
Overcoming Challenges of Working Effectively Together: Pharma And Small Providers
Optimization: Ways to optimize pharma collaborations for better outcomes.
We uncovered innovative solutions for enhancing collaboration between big pharmaceutical companies and small providers. Sheila's insights into LifeSciHub reveal a transformative approach that streamlines contracting processes, improves cost-effectiveness, and ensures access to top-tier expertise.
By addressing the hidden costs and inefficiencies in traditional outsourcing models, LifeSciHub paves the way for optimized pharma collaborations.
If you found this episode valuable, please share it with your colleagues and friends. Together, we can spread the word about these groundbreaking strategies and drive positive change in the industry.
Policies: Importance of strategic policies in digital transformation.
Build vs. Buy: Implications of building in-house solutions versus purchasing external ones.
Technology Alignment: Aligning technology strategies with business objectives.
Organizational Change: Navigating complexities in organizational change.
Actionable Advice: Practical tips for leading effective digital transformation.
Understanding and implementing the right policies are crucial for successful digital transformation. Chris’ insights on build versus buy decisions, aligning technology strategies, and navigating organizational change provide a comprehensive guide for any statistician or professional looking to lead effective change.
Don’t miss out on the full conversation packed with actionable advice and real-world examples. Listen to the episode now and be sure to share it with your friends and colleagues who can benefit from these valuable insights. Together, we can drive successful digital transformation and innovation in our organizations!
Policies: Navigating and implementing effective policies.
Communication: Clear and consistent communication strategies.
Decision-making: Effective and informed decision processes.
Mastering digital transformation and innovation requires the right mindset, emotional intelligence, effective policies, clear communication, and informed decision-making.
Chris's insights provide a valuable roadmap for statisticians and professionals aiming to lead successful change in their organizations. Don’t miss out on the full conversation where we dive deeper into these critical elements.
Listen to the episode now and share it with your friends and colleagues who can benefit from these expert strategies. Together, let's drive meaningful and successful transformation in our fields!
By understanding the differences between coaching and mentoring, and learning from Alun’s inspiring journey, you can unlock new potential and achieve greater success. Don’t miss out on these valuable insights and practical advice.
If you find this episode helpful, please share it with your friends and colleagues. Spread the word about the power of coaching and help others benefit from these transformative practices. Tune in, share widely, and start your journey towards greater achievements today.
Benefit-risk assessments: Evolution in healthcare evaluations.
Patient preferences: Importance in benefit-risk evaluations.
Tommi Tervonen: Chief Scientist at Kielo Research, an expert in MCDA and patient preferences.
Experience: Nearly two decades in benefit-risk assessments.
Structured methodologies: Importance in benefit-risk decisions.
Patient-centric approaches: Role in shaping healthcare choices.
Past, present, and future: Exploration of benefit-risk assessments.
Healthcare decisions: Impact of patient input and structured assessments.
We explore the critical role of benefit-risk assessments in healthcare, the importance of patient preferences, and how these elements shape informed decisions. Tommi's insights provided a deep understanding of the evolution and future trends in this field.
If you found this discussion valuable, share this episode with your friends and colleagues who can benefit from understanding the importance of structured methodologies and patient-centric approaches in healthcare. Let's spread the knowledge and contribute to more informed and effective healthcare decisions.
How And When To Leverage Integrated Evidence Plans (Part 2)
Data Customization: Format for different stakeholders
Efficiency: Steps to minimize duplication
Regulatory Affairs: Insights for regulatory professionals
Medical Affairs: Strategies for medical teams
Market Access: Enhancing market strategies
Knowledge Gaps: Bridging information voids
Informed Decisions: Data-driven strategies
Product Success: Lifecycle management
Join us as we bridge knowledge gaps, make informed decisions, and drive the success of your products throughout their lifecycle.
We've delved into the practical strategies and timing of leveraging integrated evidence plans (IEPs) to meet diverse stakeholder needs. By customizing data formats and minimizing duplication, statisticians can play a crucial role in ensuring the success of pharmaceutical products throughout their lifecycles. Whether you're in regulatory affairs, medical affairs, or market access, the insights shared today are designed to help you bridge knowledge gaps and make informed decisions.
If you found this episode valuable, don't keep it to yourself! Share it with your colleagues who will benefit from understanding how to effectively utilize IEPs in their work. Together, we can elevate our practices and drive greater success in the pharmaceutical industry. Tune in, share, and let's continue the conversation on how to make the most of integrated evidence plans.
How And When To Leverage Integrated Evidence Plans (Part 1)
Pharmaceutical Strategies: Align across functions and geographies
Product Lifecycle: Support throughout the lifecycle
Complexities and Significance: Dive into IEPs’ importance
Jenny Devenport: Guest with medical affairs experience
Minimizing Duplication: Crucial for efficient planning
Stakeholder Needs: Cater to various requirements
Statisticians’ Role: Shape and Influence IEPs
We dive into the essential role these plans play in the pharmaceutical industry and how statisticians can significantly contribute to their success.
Tune in to gain valuable insights and practical knowledge that will elevate your understanding and application of IEPs. Share this episode with your colleagues who will benefit from this discussion. Listen now and join the conversation!
Topics We Are Looking For The Conference in Fall 2024
Here are some key highlights of this year’s conference:
Innovative Software Platforms
Competitions and Workshops
Extended Schedule
Global Accessibility
Contributed Presentations
Volunteer Opportunities
Flexible Registration
This episode provides an in-depth look at what you can expect from the conference, including detailed discussions on how we’re using cutting-edge technology to enhance your experience, the exciting line-up of speakers and topics, and how you can get involved as a presenter or volunteer.
Whether you’re a seasoned statistician or new to the field, there’s something for everyone at this year’s conference.
Get Involved!
Don't miss this chance to be part of a dynamic and enriching event. Listen to the full episode for more details, and visit this page to learn how you can participate and contribute.
Project Management And Collaborations With Statisticians
These insights are crucial for anyone involved in clinical research aiming to achieve high-quality, timely, and budget-conscious results.
If you found this episode helpful, please share it with colleagues and friends who can benefit from these strategies and insights. Together, we can enhance the efficiency and effectiveness of clinical trials across the industry.
Early-Phase Trials on binary endpoints for decision-making.
Commitment to open-source development and collaboration.
Clinical Decision Process
Binary Endpoints
Oncology Focus
User Experience
Collaboration
Efficiency Gain
Software Engineering
User Feedback
Community Involvement
As we wrap up, it's clear that better decision-making in early-phase clinical trials is not just a necessity but a transformative step for the industry. Audrey’s innovative R package, grounded in a Bayesian framework, exemplifies how advanced statistical tools can drive efficiency and accuracy.
Don't miss out on this deep dive into cutting-edge statistical software. Listen to the full episode to learn more, and be sure to share it with your colleagues who are passionate about improving clinical trial methodologies. Together, we can drive the future of effective statistics.
Career Elevation: How accreditation enhances your professional status
Building Trust: Importance of accreditation in establishing expertise
FENstatS Accreditation: Process and significance
Expert Insights: Magnus Pettersson’s experience and perspective
Rigorous Process: Understanding the steps involved in accreditation
Professional Standards: Upholding ethical and communication standards
AI and Data Science: Relevance of accreditation in evolving fields
Application Process: Tips for achieving FENstatS accreditation
Continuous Development: Importance of ongoing professional growth
Leadership and Trust: Building credibility in the profession
The FENstatS accreditation offers a valuable opportunity for statisticians to elevate their careers, uphold professional standards, and build trust in their expertise, especially in the dynamic fields of data science and artificial intelligence.
By engaging in this rigorous process, you demonstrate your commitment to excellence and continuous development.
Don’t miss Magnus Pettersson’s expert insights and practical tips. Tune in to this episode of The Effective Statistician, and share it with your colleagues and friends to spread the word about the importance of accreditation in our profession.
Listen now and take the first step towards enhancing your professional journey!
Career Boost: Explore how networking can significantly enhance your career as a statistician.
Introverts: Address the challenges introverts face in networking.
Importance: Understand why networking is crucial for professional success.
Practical Advice: Learn how to initiate and maintain professional connections.
Office Networking: Tips for networking within your organization.
Conferences: Benefits of attending and networking at conferences.
Professional Associations: Importance of joining and participating in associations.
Career Insights: Gain valuable insights and seize new opportunities through networking.
Effective Strategies: Comprehensive guide to effective networking strategies for statisticians.
Mastering the art of networking is essential for enhancing your career and seizing new opportunities as a statistician. By implementing the practical strategies discussed in this episode, you can build meaningful professional connections, gain valuable insights, and navigate your career path more effectively.
If you found this episode helpful, share it with your friends and colleagues. Let’s help each other grow and succeed in the world of statistics.
Simple Solutions: Focusing on fundamental, proven methods.
If you enjoyed this episode, share it with your friends and colleagues. Your support helps us reach more statisticians and data scientists, keeping us all informed and proactive in our work. Don’t forget to subscribe for more episodes featuring expert advice and industry insights.
Navigating New Teams: Building Trust and Avoiding Pitfalls
All-in-all, successfully integrating into a new team requires patience, understanding, and strategic actions. By focusing on building trust, listening actively, and being adaptable, you can establish strong relationships and set the foundation for future contributions.
Remember, your initial efforts in understanding the team dynamics and culture will pay off in the long run, allowing you to introduce innovative ideas more effectively and gain the trust and respect of your colleagues.
If you found this episode helpful, please share it with your friends and colleagues who might benefit from these insights. Helping others navigate their new roles more effectively can contribute to a more collaborative and productive work environment for everyone.
Let's spread the knowledge and support each other's professional growth!
The Current State Of EU HTA: Large Challenges Ahead!
This episode provides crucial insights into the evolving landscape of EU Health Technology Assessment (HTA) and the significant challenges ahead.
Stefan Walzer’s expertise sheds light on the pressures on pricing, clinical requirements, and the upcoming European Joint Clinical Assessment (JCA).
If you’re involved in the healthcare industry or have a keen interest in market access and health economics, this episode is a must-listen. Don’t keep these valuable insights to yourself—share this episode with your friends and colleagues who can benefit from understanding these pivotal developments.
Tune in now and join the conversation on shaping the future of healthcare in Europe.
Take Control of The Perceptions Others Get From You Online!
Digital Footprint and Importance of your digital presence.
Online Perception
Professional Online Profile
Career Opportunities
LinkedIn Optimization
Building Trust
Visibility
Networking
Content Sharing
Professional Growth
In today's digital age, your online presence is more important than ever. By taking control of how you're perceived on platforms like LinkedIn, you can unlock new career opportunities and build valuable professional relationships.
If you found this discussion helpful, please share this episode with your friends and colleagues who could also benefit from these tips. Let's help each other make the most of our online presence and advance our careers together.d a trustworthy and supportive community.
The FAIRification Of Research In Real-World Evidence: A Practical Introduction To Reproducible Analytic Workflows Using
Challenges and opportunities in Real-World Evidence (RWE)
Git and R Integration
Janick Weberpals’ Journey
Best Practices in Coding
Collaboration and Accessibility
Implementation Steps
This episode offers invaluable insights into the importance of reproducible analytic workflows and the application of the FAIR principles in real-world evidence research. By integrating tools like Git and R, researchers can enhance transparency, collaboration, and the reliability of their findings.
We hope you found this discussion with Janick Weberpals both informative and inspiring.
If you believe your friends and colleagues can benefit from these practical
Trust - The Fundament of Your Success And How To Built It (Part 3)
Building trust through character is a fundamental aspect of professional success. By keeping promises, being honest, actively listening, and supporting others, we lay the groundwork for lasting and meaningful relationships.
Embrace these principles and watch how they transform your interactions and reputation. If you found this episode insightful.
Share it with friends and colleagues who can benefit from these valuable lessons. Let’s spread the knowledge and help each other build a trustworthy and supportive communit
This episode provides invaluable insights into the powerful role of company culture in driving innovation and making data-driven decisions. Matt's experiences and strategies offer a blueprint for creating a fulfilling and impactful work environment.
Trust - The Fundament of Your Success And How to Build It (Part 2)
By understanding and applying these key concepts, you can significantly enhance your ability to communicate data effectively and discover valuable insights.
If you found this episode insightful, please share it with your friends and colleagues. Let's spread the knowledge an
Trust - The Fundament of Your Success And How to Build It (Part 1)
Building trust within your team is not just an abstract concept; it’s a tangible and critical skill that can significantly enhance your professional relationships and success. By focusing on competence, character, and care, you can establish a foundation of trust that leads to more effective collaboration and better outcomes. I hope you found the insights and strategies shared in this episode valuable and are ready to implement them in your own work environment.
If you know friends or colleagues who could benefit from this discussion on trust, please share this episode with them. Together, we can foster a cu
Exploration Or Explanation: 10 Key Differences For Data Visualisations
By understanding and applying these key concepts, you can significantly enhance your ability to communicate data effectively and discover valuable insights.
If you found this episode insightful, please share it with your friends and colleagues. Let's spread the knowledge and elevate the standards of data visualization in our professional community.
How To Convince Others By Not Making This Mistake!
Remember the power of emphasizing benefits over features when trying to convince others. By focusing on what people gain, you make your message more compelling and persuasive.
I hope the insights shared today help you improve your communication and persuasion skills. If you found this episode valuable, pleas
What You Can Expect And How You Can Contribute To The Conference In November 2024
Don’t miss out on this episode to get all the details on our upcoming November 2024 conference.
Whether you’re looking to contribute, learn, or network, this episode is packed with valuable insights to help you maximize your participation and impact.
Tune in now, explore the opportunities awaiting you, and consider sharing this episode with friends and colleagues who could also benefit from joining this transformative event. Together, let’s advance our practice and make a significant mark in the field of healthcare statistics!
One Thing You Need As A Leader, That Is Not A Skill But A Choice
Discussion with Alexander
In this episode, we merge the worlds of statistics, leadership, and personal growth.
I am eager to navigate the "4+1 phases of learning" with you today. This topic, central to our leadership course, particularly targets supervisors but resonates with everyone in a professional setting.
It’s crucial for both effective delegation and understanding our personal development in skills and tasks.
This episode aims to guide you through recognizing your learning phase, whether it’s identifying the unknowns in your skills or reaching a point where you can mentor others. We're discussing a framework to enhance how we learn, teach, and lead.
Retention Of People: How To Keep Your Statisticians - As A Supervisor
If this episode enlightened you, please share it with your friends and colleagues who might also benefit from understanding these critical interactions.
How To Learn And Get Better On Your Influencing Skills
Mastering these skills is essential, as being the best technical expert isn't enough if you can't drive change or enhance methodologies within your team.
Share this valuable knowledge with your friends and colleagues, empowering them to unlock their full potential and drive positive change in their teams and organizations.
Acknowledging that every methodological choice has its trade-offs and costs.
Tune in to deepen your understanding of bias and precision in statistical analysis, and don't forget to share this insightful discussion with your colleagues!
If you're intrigued by the complexities of placebo responses and want to gain valuable insights into how they influence clinical trial outcomes, listen to this episode. Share it with your colleagues and peers to deepen your understanding of placebo's role in medical research.
Data Visualisation - A Great Topic For Building Your Reputation
Communicating patterns, trends, and insights effortlessly
Advantages Over Other Statistical Techniques
Contrast with techniques requiring extensive explanation
Active communication through visual representation
Building Reputation Through Data Visualization
Leveraging clarity for personal branding
Enhancing visibility and recognition within the statistical community
I urge you to take action on the insights. Remember, data visualization isn't just a tool—it's a pathway to clearer communication, enhanced reputation, and greater impact in the statistical community.
If you've found value in today's discussion, share this episode with friends and colleagues who can benefit from it.
Together, let's empower one another to master data visualization and elevate our collective expertise.
Listen now and gain invaluable strategies for fostering trust, managing conflict, fostering commitment, ensuring accountability, and driving towards impactful results within their own teams. Tune in for an enlightening journey through the intricacies of team dynamics, and discover how to cultivate a culture of collaboration, excellence, and success.
Share this episode with your friends and colleagues who can benefit from this!
Why To Be A Volunteer And How To Become One Within The Effective Statistician Community
Let your company understand your value through the evidence of your work
Take the initiative to make the change
Remember, understanding and communicating your true worth is essential for both personal and professional growth. By defining yourself beyond your company's expectations, embracing your uniqueness, and taking the initiative to drive change, you can create immense value for yourself and your organization.
Mastering the Art of Learning: From Novice to Expert in BI Training
Essential for effective delegation and team management
Guidance for individuals and leaders
From unawareness to unconscious competence
Enhancing statistical acumen
Refining leadership and interpersonal skills
Navigating the learning curve
Personal and professional growth exploration
Share this episode with your friends and colleagues to spread the valuable lessons and insights it offers for professional and personal growth. Let's learn and grow together!
Data collection and design for individual patient benefit
Observational data and randomized trials
Leveraging existing data sources
Importance of standardization
Integrating multiple studies and data types
Future of personalized medicine in various indications
If you found this episode enlightening, we encourage you to share it with friends, colleagues, and anyone who stands to benefit from a deeper understanding of personalized medicine's potential and pitfalls.
Together, we can advance the conversation and move closer to a future where healthcare is as unique as the individuals it serves.
Importance of translating data insights into actionable strategies
Focus on reaching the right audience and driving meaningful outcomes
Selena's innovative approach to data strategy for businesses
Tailoring data plans to organizations' goals and maturity levels
Addressing challenges of data overload and providing clarity for leaders
Overview of Selena's "Make Data Talk" podcast and its mission
Advocacy for global data literacy initiatives
Application of data strategy principles in education for student success
Conclusion emphasizing the pivotal role of data strategy in our digital landscape
Selena has been enlightening, showcasing the power of data storytelling and its impact on various sectors, from education to corporate settings.
Now, it's your turn to spread the knowledge! Share this episode with your friends and colleagues who could benefit from learning more about data literacy and how it can drive positive change.
Together, let's empower more individuals and organizations to harness the power of data for a better future.
Typical Challenges in Outsourcing and How to Overcome Them
Discussion with Alexander Schacht and Benjamin Piske
Key Points:
Necessity of Outsourcing
Essentials of Successful Outsourcing
Anticipated Challenges
Taking Care of Outsourced Teams
Effective Strategies
Benefits of Outsourcing
Navigating the challenges of outsourcing in statistics and data analysis requires a strategic approach and a commitment to effective communication, collaboration, and careful planning.
By addressing these challenges head-on and implementing the strategies discussed in this episode, statisticians and data analysts can harness the power of outsourcing to enhance their capabilities, meet project demands, and drive success in their organizations.
CRO staff will also benefit from this episode.
Share this episode with your friends and colleagues to spread the knowledge and empower others in our field to overcome outsourcing challenges and achieve excellence in their work.
Together, we can foster a community of informed and skilled professionals dedicated to advancing the practice of statistics and data analysis.
Where's Motivation Coming From? For You And Your Colleagues
Marketing helps bridge that gap between complex data and real-world impact.
What are the key takeaways here?
Marketing is more about listening than it is about broadcasting. Understanding your audience’s needs and preferences is crucial for effective communication.
Know who your stakeholders are and what they expect from you. Meeting (or exceeding) those expectations builds trust and credibility.
Keep an eye on your competitors, but don’t let them dictate your strategy. Use their presence as motivation to innovate and improve.
Putting on your marketing hat now and then can elevate your statistical prowess to new heights. So, embrace it, experiment with it, and watch how it transforms not only your work but also your impact on the world.
The Effective Statistician Academy: Call For Trainers!
You get support from a fully-equipped team who understands how to get your message out. This allows you to focus on teaching and making your lessons more interesting.
You get all the personal promotion you can get. You teach with us; you get access to a huge network of statistics enthusiasts.
We spearhead the growth of your career through making lessons valuable for everyone who wants to understand the importance of statistics in healthcare.
We prepare both online and offline trainings that you can join and reach out to your target market.
Ready to become a part of The Effective Statistician Academy?
Contact me today and I will be more than ready to welcome you along with our other highly esteemed trainers.
You're not paid for your performance. But for your perceived value!
It’s not what you think is valuable- it’s what your stakeholders think is valuable: Shift your focus from your perspective to that of your stakeholders to truly understand and deliver what they value.
Make them understand your worth through tangible evidence: Back up your claims of value with concrete examples, metrics, and outcomes to demonstrate the impact of your contributions.
Build-Up on Intrapreneurship instead of Entrepreneurship: Embrace the mindset of an "intrapreneur" within your organization, seeking out opportunities for innovation, growth, and value creation.
By mastering the art of leveraging your perceived value, you can propel your career forward and achieve greater success in the dynamic field of statistics.
Learn more about how you create your value and turn your new perceived personal and professional worth into becoming the basis of your company’s growth. Listen to this podcast episode now and improve your role in the company.
Share this with your friends and colleagues who might benefit from it!
Introduction To Personalized Medicine Part 1: Exploring the Future of Healthcare
● How Does Personalization of Medicine Improve Intervention Results?
Key Highlights
● Addressing Individualized Benefit: The personalized medicine approach recognizes that each patient is unique and strives to optimize treatment strategies based on individual characteristics and needs.
● Enhancing Efficacy: By leveraging personalized data, healthcare providers can fine-tune interventions to better target diseases, resulting in improved treatment outcomes and patient well-being.
● Balancing Pros and Cons: While personalized medicine holds tremendous promise, it's essential to weigh the potential benefits against ethical, social, and economic considerations to ensure responsible implementation.
As reach into the realm of personalized medicine, it's evident that we stand at the precipice of a transformative era in healthcare. With its emphasis on individualized care and tailored interventions, personalized medicine offers a beacon of hope for patients and practitioners alike.
Stay tuned for the next episode of our exploration, where we'll dig in deeper into the practical applications and prospects of this groundbreaking approach.
Thank you for tuning in to the Effective Statistician Podcast. Until next time, stay curious and keep exploring the frontiers of statistical science in healthcare.
My Learnings From Organising The 2nd Conference Of The Effective Statistician - Part 1
The Importance of Communication
- Strategies employed to promote the conference, including social media and email campaigns.
- The necessity of utilizing multiple channels to reach a diverse audience effectively.
Having a Plan B
- The unforeseen challenges of event planning and the importance of contingency planning.
- Real-life example of addressing a last-minute speaker cancellation.
The Power of Networking
- How a strong professional network can be a lifeline in times of need.
- Personal outreach and its role in securing speaker commitments and fostering community support.
Learning from Past Experiences
- Adjustments made based on feedback from the first conference.
- Implementing practical solutions to improve event structure, such as session timing and technical preparations.
The Value of Delegation and Building a Team
- The role of teamwork in managing complex event logistics.
- Examples of how collaboration enhanced the conference's promotional efforts and overall execution.
Thinking Big
- Encouragement to set ambitious goals and reach out to prominent figures within the industry.
- The benefits of expanding the conference scope and daring to dream larger.
Awesome Community
- Reflections on the supportive and collaborative nature of the statistics community.
- Plans for future conferences, including opportunities for community engagement and knowledge sharing.
In wrapping up our exploration into the intricacies of organizing a successful conference, it's clear that the journey is as rewarding as it is challenging.
The Effective Statistician's 2nd conference not only exemplified the power of community, communication, and continuous learning but also highlighted the invaluable lessons that come with stepping out of our comfort zones to create something meaningful.
As we look forward to future gatherings and the boundless opportunities they present, let's carry forward the spirit of collaboration, innovation, and ambition that defines our community. Together, we can continue to push the boundaries of what it means to be an effective statistician, fostering a future where our collective knowledge leads to greater achievements and advancements in healthcare and beyond.
Here are some of the highlights of this enriching conversation:
Embracing open source integration
Advancement in generative AI
Data Scalability and Reusability in Analytics
Overall, this podcast opens new doors to innovation in statistical analytics through SAS by
partnering with Microsoft and harnessing the power of open AI libraries. In this presentation,
SAS is highlighted to be developing intelligent assistants like CoPilot to facilitate code
generation and streamline programming workflows.
This innovative approach not only accelerates the pace of analysis but also enhances
collaboration and knowledge sharing among diverse teams, transcending language barriers and
fostering a culture of innovation.
As the healthcare landscape continues to evolve, SAS remains at the forefront, equipping users
with the tools and resources needed to navigate the complexities of modern data analysis. With
Mark Lambrecht's insights, listeners gain valuable perspectives on the transformative potential
of analytics in healthcare, setting the stage for a future where data-driven decisions drive
improved patient outcomes and revolutionized the practice of medicine.
What You Can Expect from The Effective Statistician Conference and More News
Introduction to the Effective Statistician Conference
Overview of the upcoming conference
High level of registrations as an indicator of anticipation
Expectations for three days of learning and networking
Highlighting Key Speakers and Topics
Discussion of notable speakers and their areas of expertise
Overview of topics ranging from precision medicine to leadership principles
Importance of each presentation in advancing statistical knowledge and skills
Encouraging Participation and Engagement
Invitation for registration and participation in the conference
Emphasis on the benefits of live attendance versus recorded sessions
Introduction of a nominal fee for conference recordings to encourage active learning
Future Plans and Innovations
Sneak peek into plans for future conferences
Introduction of contributed presentations for upcoming events
Expansion of conference sessions to accommodate global time zones and online networking opportunities
The conference promises to be an invaluable resource for statisticians seeking to enhance their skills, expand their knowledge, and connect with industry experts.
With a lineup of esteemed speakers covering a diverse range of topics, this event offers a unique opportunity for professional development and networking.
Don't miss out on this chance to elevate your statistical expertise and be part of a vibrant community of like-minded professionals. Secure your spot in shaping the future of statistics. We look forward to welcoming you to this exciting conference and exploring the limitless possibilities together.
This episode shines a light on the often overlooked yet incredibly potent tool of structural equation modeling. Through Christian's expertise and practical examples, you'll receive a thorough introduction to SEMs, from their theoretical foundations to their diverse applications in research. Whether you're an experienced researcher or new to the field, this episode delivers valuable insights on how SEMs can enhance your analytical skills and refine the accuracy of your research findings.
So share this link with your friends and colleagues!
This episode is a must-listen for anyone eager to enhance their impact in the workplace through strategic project selection and execution.
Dive into the heart of the statistics industry at The Effective Statistician Conference, where industry luminaries like Andy Grieve, Chrissie Fletcher, and Anja Schiel will share invaluable insights. This event promises to be a cornerstone for statisticians eager to enhance their impact and knowledge, with discussions ranging from technical talks to guidelines shaping our field. With free live attendance, it's an exceptional opportunity to connect, learn, and be inspired. Register now to secure your spot in this transformative experience! Click Here!
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Why You Should Attend The Effective Statistician Conference!
Now that we've uncovered the keys to transforming your organization's approach to statistical results, it's time to take action. Reflect on the challenges you've faced in data storage, accessibility, and collaboration within your organization.
Make sure to share this episode with your friends and colleagues that can benefit from this!
The Motivation Behind The Podcast: Reflecting on my podcast journey and the evolving clarity on why I've been committed to sharing statistical insights for several years.
Navigating Critical Health Decisions: Drawing from personal experiences as a patient, brother, husband, and father, and the challenges faced when seeking understandable evidence.
Challenges in the Statistics Community: Addressing the gaps in influencing decisions, from research to healthcare investments, due to insufficient statistical understanding.
Unveiling the Change Agent Program: Introducing a transformative program designed for statisticians eager to make a significant impact and drive change in the industry
Curriculum Overview: Delving into the comprehensive curriculum covering leadership, strategy, communication, and the art of leading change.
Building a Community: Exploring the importance of building a community of like-minded individuals to drive impactful change collectively.
Developing Products for Change: Understanding how to develop products—ranging from training to tools—that can be easily distributed to maximize impact.
Weekly Group Coaching Calls: Unveiling the magic that happens in the weekly group coaching calls, where change agents come together, share experiences, and support each other.
How to Apply: Providing details on how passionate statisticians can apply for the Effective Statistician Change Agent Program and take the first step towards becoming a transformative force.
Are you ready to be a part of this transformative journey and shape the future of statistics in healthcare? Dive into the full episode to discover more about the program and how you can become a change agent in the statistical landscape. Let's drive impactful change together!
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Detailed Analysis of Situational Leadership Scenarios
Scenario 1: Unskilled and Unfamiliar
a. Delegation approach for very junior individuals
b. Importance of detailed explanation and feedback
Scenario 2: Unskilled but Familiar
a. Dealing with frustration and lack of knowledge
b. Encouragement and supportive feedback
Scenario 3: Skilled but Still Learning
a. Transitioning to larger tasks
b. Delegating deliverables and emphasizing goals
Scenario 4: Highly Skilled and Natural
a. Recognizing when tasks become second nature
b. Avoiding assumptions about others' skills and experiences
Leadership by Intent
a. Emphasizing the importance of explaining the 'why' behind tasks
b. Encouraging goal-oriented delegation for skilled individuals
Continuous Learning and Growth
a. Acknowledging that expertise is task-specific
b. Encouragement for experienced individuals to take on new challenges
Training and Support in Delegation
a. Addressing the common issue of leaving new supervisors unsupported
b. Importance of training and guiding individuals taking on supervisory roles
Stay tuned for more valuable insights and leadership content, and remember—effective delegation is not just about assigning tasks; it's about empowering individuals to contribute meaningfully to shared goals. Happy listening!
We invite statisticians to reflect on the evolving landscape of estimands, encouraging thoughtful consideration of estimation techniques and a deeper exploration of causal inference in clinical trials. The journey through this nuanced statistical terrain unfolds, offering valuable insights for both seasoned professionals and newcomers to the field.
Keene ON, Ruberg S, Schacht A, Akacha M, Lawrance R, Berglind A, Wright D. What matters most? Different stakeholder perspectives on estimands for an invented case study in COPD. Pharmaceutical Statistics. 2020 Jul;19(4):370-87.
https://pubmed.ncbi.nlm.nih.gov/31919979/
Other references:
Naitee Ting (2023) Emerging insights and commentaries – MMRM vs LOCF, Journal of Biopharmaceutical Statistics, 33:2, 253-255, DOI: 10.1080/10543406.2023.2184828
Wright D, Bratton DJ, Drury T, Keene ON, Rehal S, White IR. Response to Comment on” Emerging insights and commentaries–MMRM vs LOCF by Naitee Ting”. Journal of Biopharmaceutical Statistics. 2023 Sep 23:1-3.
Keene ON. Adherence, per-protocol effects, and the estimands framework. Pharmaceutical Statistics. 2023;1‐4. doi:10.1002/pst.232
Keene ON. Intent-to-treat analysis in the presence of off-treatment or missing data. Pharmaceutical Statistics 2011, 10:191–195, doi: 10.1002/pst.421.
Keene ON, Wright D, Phillips A, Wright M. Why ITT analysis is not always the answer for estimating treatment effects in clinical trials. Contemporary Clinical Trials. 2021 Sep 1;108:106494.
Keene ON, Lynggaard H, Englert S, Lanius V, Wright D. Why estimands are needed to define treatment effects in clinical trials. BMC Medicine. 2023 Jul 27;21(1):276.
What is the ASAP and what you should know about it
The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule).
Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potential risks associated with a drug or vaccine.
In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting.
This process will develop a better understanding of the safety profile of drugs and ensure that patients’ safety is well-thought-of.
Sources and references:
Ball G, Kurek R, Hendrickson BA, et al (2020). Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions. Therapeutic Innovation & Regulatory Science, 54(2):447-461
Ball G, Hendrickson BA, Freedman AL, Gordon R, Crowe B, Veenhuizen MF Buchanan J (2021). Interdisciplinary Safety Evaluation for Learning and Decision-Making. Therapeutic Innovation & Regulatory Science, 55:705-716.
Hendrickson BA, Wang WW, Ball G, et al (2021). Aggregate Safety Assessment Planning for the Drug Development Life Cycle. Therapeutic Innovation & Regulatory Science, 55:717-732.
Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). He co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.
Trends That Will Have an Increasing Impact on Our Work
Trend 2: Transparency in Data and Privacy Concerns
Trend 3: Virtual and Augmented Reality in Work Environments
Trend 4: Collaboration through Specialized Marketplaces
Trend 5: Open Source Programming and Collaboration
Trend 6: Payer Involvement in Drug Development
In this thought-provoking episode, Benjamin and I provide valuable insights into the dynamic trends shaping the statistical landscape. From AI and data transparency to virtual reality and payer involvement, statisticians are navigating a rapidly evolving terrain. As the industry adapts to these trends, staying informed and embracing new approaches becomes paramount for effective statistical work in drug development. Tune in and stay ahead of the curve!
Share this with your friends and colleagues that can benefit from this!
Creating Opportunities through Networking: Networking played a pivotal role in my career shift from internal to external collaborations, notably joining the Benefit Risk Special Interest Group of ESFPI and PSI.
Providing Training as a Networking Opportunity:Providing training is a rewarding avenue, amplifying visibility and unlocking opportunities by showcasing expertise and building connections.
Opportunities Arising from Interesting Projects: Participating in impactful projects is transformative. Leading a digitalization effort in my career enabled hosting a companywide event on data visualization, fostering lasting connections and future collaborations.
External Collaborations and Conferences:External collaborations, like special interest groups and conferences, are key for expanding networks. Go beyond talks – actively network with key figures.
Preparation and Confidence: Boost confidence by maintaining a daily achievements diary and reflecting on past successes. Essential for career progression is investing in leadership and presentation skills.
Encouraging Opportunities Within Teams: Leaders, empower your teams to seize opportunities and thrive within a conducive culture.
So, my fellow statisticians, as you navigate the twists and turns of your statistical career, remember that luck favors the prepared.
Actively create opportunities through networking, training, engaging in exciting projects, and building confidence. Be proactive, invest in your skills, and be ready to seize those lucky moments.
You can also join our exclusive three-day strategy workshop tailored for statisticians, data scientists, and programmers like yourself. Together, let’s break down barriers, foster innovation, and craft a roadmap for your personal and business growth.
Whether you're a seasoned statistician or a curious listener, the insights shared about observational studies, Estimand frameworks, and the future of real-world data research are bound to leave you with a wealth of knowledge.
Share this with your friends and colleagues who would benefit from this. Tune in now!
Unveiling Belief Systems: Explore the concept of "Glaubenssatz" and how it shapes your reality.
The Power of Thoughts: Discover how your thoughts influence your actions and outcomes.
Breaking Limiting Beliefs: Learn practical strategies to overcome barriers and achieve your goals.
Impact on Your Career: Navigate through common beliefs affecting your professional journey.
Embrace Growth: Embody a growth mindset for personal and professional transformation.
As 2023 transitions into 2024, Mirjam encourages listeners to set meaningful goals, providing the motivation to overcome fears and challenge limiting beliefs.
So, here's to breaking free from mental chains and unlocking your true potential!
Share this with your friends and colleagues who can benefit from this.
In a world where strategy is often misunderstood, this episode serves as a valuable resource for unraveling the true essence of strategy. Empowered by insights from historical examples and a comprehensive approach, you can develop and implement effective strategies in their professional and personal journeys.
For those seeking a deeper dive into the realm of strategy, an upcoming workshop in Frankfurt offers an opportunity to establish personal strategies for success.
As I look forward to providing more content in the coming year, you can anticipate a wealth of insights and guidance to navigate the strategic landscape.
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From Ethics Guidelines to Implementing Ethical Statistics
Perspective on Ethics:
Not just labeling actions but determining good behavior is crucial in our diverse global landscape.
Driving Change:
Actively create awareness and understanding through various ways.
Building Trust:
Demonstrate care, competence, and character.
Advocacy Beyond Community:
Articulate societal and environmental implications.
Holistic Education:
Emphasize algorithmic thinking and service statistics.
Policymaking:
Highlight importance of evidence-based decision-making. Advocate for transparent processes.
Organizational Change
Find allies for effective collaboration. Strength in numbers for real transformations.
The journey toward ethical statistics is collective, involving active implementation, effective communication, collaboration, and a commitment to building trust. It's a shared responsibility with far-reaching impacts on our societies and the world at large.
Listen to this episode now and share this with your friends and colleagues who can benefit from this!
The Genesis of Estimands:
A conversation in 2017 that led to the creation of the Estimands Framework, a shared language to simplify complexity in clinical trials.
A Closer Look at Depression Studies:
Me and Elena strategically chose depression as their focus for research due to its unique challenges, including efficacy, maintenance, intercurrent events, and time-to-event endpoints.
The Practical Guide:
A collaborative effort between stakeholders has produced a practical guide to help study teams better understand and utilize the Estimands process for clinical trial design.
Regulators on Board:
Getting the support and validation of regulatory bodies was an essential factor in the success of the Estimands Framework.
A Blueprint for Progress:
The Estimands Framework, developed by me and Elena, enhances the pharmaceutical industry by providing a path towards greater precision, clarity, and collaboration in clinical trials.
Listen to this episode now and share this with your friends and colleagues!
Cross-Over Studies: When Do They Offer a Great Advantage?
This episode highlights the critical significance of comprehending crossover studies in the realm of scientific research. These studies enable a profound analysis of treatment effects, fostering innovative discoveries and ultimately enhancing patient outcomes. Understanding the complexities of crossover designs is pivotal for researchers, providing a robust framework to delve into intricate treatment nuances and pave the way for impactful advancements in the field.
Listen to this episode now and share this with your friends and colleagues!
Understanding the Numbers: A Prelude to Negotiation
I emphasize the need for innovative solutions to rising costs in table production, stressing that understanding the essence of negotiation is crucial in a world where numbers matter.
Stories of Success: Reducing Tables Through Strategic Thinking
Through two stories, I illustrate the potential of negotiation, including reducing tables and restructuring them to create savings.
The Art of Negotiation: Key Insights
Active listening is a powerful tool in negotiation that helps negotiators understand each other's needs and concerns to reach mutually beneficial agreements.
Leadership Skills: The Cornerstone of Success
Investing in leadership skills is necessary for teams striving to reach excellence.
A Beacon of Excellence: The Leadership Training Program
Gary Sullivan and I pioneered an innovative leadership training program that provides professionals with the necessary skills for success in negotiation and leadership.
Modular Table Production: A Cost-Effective Innovation
My modular table production concept strategically reduces costs, increases efficiency, and ensures consistency in the production of repeat tables.
Listen to this episode as I illustrate the importance of having leadership skills and effective negotiation techniques to be successful in the ever-evolving landscape of statistics.
Understanding Risk Management
They discuss the importance of continuous risk assessment and proactive planning throughout a clinical trial's lifecycle.
Risk Identification
We discuss the importance of collaborative risk identification, the role of assumptions in assessment, and aligning team members' timelines for successful project completion.
Risk Assessment
Jess explains the importance of collaboration and input from team members when assessing risks using a 1 to 10 scale in order to accurately evaluate the likelihood and impact of identified risks.
Contingency Planning
Risk scoring, mitigation options, risk tolerance, contingency planning, and documentation/communication are essential for successful risk management.
Risk Reporting and Lessons Learned
Status reporting is an important tool for activating necessary plans, recognizing successes, and fostering a collaborative atmosphere while also documenting risks.
Share this episode with your friends and colleagues who can learn from this!
Ethical Guidelines for Statisticians - Why and What
The World Statistics Congress in Ottawa:
Katharina shares her experience at the World Statistics Congress and the importance of ethical discussions among statisticians.
Ethical Concerns and Responsibilities:
Ethical concerns in data algorithms and statistics are prevalent within the professional community.
Challenges in Communicating Statistics:
We emphasize the role of statisticians in transparent communication and avoiding misleading interpretations in public discourse.
Values in Ethical Guidelines:
The discussion delves into the importance of putting patients first in medical statistics and considering the bigger picture in statistical analyses.
Ethical Responsibilities in Artificial Intelligence:
The conversation touches on the ethical implications of artificial intelligence and machine learning methods.
Spreading Awareness and Promoting Ethical Guidelines:
We explore the use of gamification and interactive learning to enhance understanding of statistical concepts and assumptions.
Katharinaencourages listeners to reflect on ethical aspects in their daily statistical practice and embrace the responsibilities of statisticians.
She emphasizes the significance of effective communication skills for statisticians and their role as leaders in data-driven decision-making.
Listen to this episode now and share this with your friends and colleagues!
Working in an Under-Resourced Environment and What to Do
Transitioning from SAS to R can be intimidating. Still, with the advice of professionals like Thomas and myself, it can be a smooth and painless process. This episode highlights essential tips that users can incorporate as they move forward in their journey from SAS to R. With the essential skills under your belt, you'll be sure to be successful in your transition to R.
Interested to learn more? Check out the links and course:
What is Health Technology Assessment and how is it used to assess the added benefit of a drug on a patient level?
What are the Minimal Important Difference (MID) and Minimal Clinical Important Difference (MCID) and how are they assessed through patient surveys to ensure drug efficacy?
Why is the 15% threshold important and why can it be difficult to reach due to statistical issues arising from continuous outcomes?
Why should statisticians working in development consult with HTA statisticians early on in study design to create evidence that will meet the threshold?
How does the scale of the endpoint impact drug reimbursement and can a drug be reimbursed if patients show 14% improvement in one area but a 17% improvement in another?
The 15% threshold is an essential element of the HTA system in Germany, and it's crucial for statisticians beyond market access experts to understand how it affects the HTA process in Germany and beyond.
By following best practices and involving HTA statisticians from the beginning stages of a study, you can create reliable evidence that meets the 15% threshold. By doing so, you can help ensure that essential drugs reach patients, improving their quality of life.
Share this very insightful episode with your friends and colleagues who might benefit from this!
What Young Statisticians and Likely Others Expect from Their Management
Building a network to find job opportunities and get referrals.
Attending events and joining industry organizations.
Visibility online is essential.
Keeping skills and knowledge up-to-date
A track record of achievements should be built
An emergency fund should be set aside in the event of job loss.
Even in the face of uncertain times, taking these steps can keep you ready to tackle your next professional challenge with gusto!
If you need more help, joining the Clivoffective network provides access to additional resources and insights on job security. This community can offer support and help individuals build their network, increasing their chances of finding new opportunities.
Share this information with your friends and colleagues to help them get ready for these uncertainties, too!
The advantages of teaming up with a professional podcast producer and manager
How The Effective Statistician keeps on growing and building a great audience
If you're interested in starting a podcast, consider working with a professional production and management team like the one that Reine leads - VVS.
With their expertise, you can create engaging content, build a loyal audience, and grow your brand. Today's episode shows that starting a podcast requires a balance of technical skills, creativity, and marketing know-how.
If you're passionate about a topic and have a unique perspective to share, you can join the growing ranks of successful podcasters. We hope this blog post has been informative and helpful, and we wish you all the best on your podcasting journey!
Interview with Gary Sullivan
You have to be extroverted to be a leader.
Only if you have employees are you a leader.
Either you have it or you don't. Leaders have a natural gift, you can't learn it.
Those are three typical myths about leaders. In today's episode, I talk with Gary about these three false beliefs. We point out why they're false and give some counterexamples.
We also discuss why they limit your development and make you a victim, so to speak.
As statisticians, we are often introverted. We can use this to our advantage. We can take leadership, in our cross functional teams. And we can learn these leadership skills as well.
All good leaders are always learning.
Listen to the latest episode and share it with your colleagues.
Three Things to Learn About Yourself That Will Make a Huge Difference
Intrinsic motivation - the driving force behind personal growth. It is the energy that keeps you going towards achieving your goals.
Courage - It takes courage to step out of your comfort zone, take risks, and embrace new opportunities.
Self-confidence - your belief in your abilities and potential. Without self-confidence, it is challenging to take risks and pursue significant achievements. As a statistician, you need to trust your knowledge and skills and have the confidence to tackle complex projects.
Whether you are a statistician just starting your career or a seasoned professional, personal and professional growth is crucial for success. The journey toward growth starts with a deep understanding of yourself.
Listen to this episode now and share this with your friends and colleagues!
Taking Out the Pain of Paperwork: How Sponsors and Small Businesses and Individual Experts Work Smoothly Together
How can statisticians become change agents and overcome the barriers to innovation?
What skills do we need to improve?
What are the next steps?
Successful strategies for promoting innovation include starting small, being collaborative, taking risks, and focusing on real-world problems. To become effective change agents, statisticians need to improve their communication, leadership, and adaptability skills. And the next steps for promoting innovation in drug development statistics include investing in education and training, fostering more collaboration and networking opportunities, and continuing to advocate for the importance of statistical innovation.
Listen to this episode now and share this with your friends and colleagues!
Driving Statistical Innovation - Barriers And Strategies Part 1
The interplay between invention and commercialization for statistical inventions.
Potential barriers to success include lack of knowledge/software, resistance to change, and short-term goals over long-term initiatives.
Strategies for success include:
Clear communication
Patience/resilience in long-term initiatives
Providing resources/training, promoting diversity/inclusion in teams
Networking/communication skills, collaboration with other functions, pragmatism/compromise for success
Freedom to innovate
Setting up a community of statisticians.
We provide valuable insights into driving statistical innovation, overcoming barriers, and strategic planning. The success of statistical innovation requires clear communication, patience, resilience, collaboration, innovation, and pragmatism. By leveraging external resources and setting up a community of statistical methodology leaders, we can bring value to patients and overcome statistical challenges in the pharmaceutical industry.
Learn more by listening to this episode now and share this with your friends and colleagues!
Companies in the pharmaceutical industry must differentiate their compound from other competitors for successful market performance.
The value dossiers and data visualizations to set the company apart.
Data visualizations are used to demonstrate superiority to target customers and secure pricing/reimbursement.
How can you improve your data visualization skills?
Join the Data Visualization Special Interest Group, which is an online community of professionals committed to improving their data visualization skills. The group hosts regular events and discussions on best practices and new tools and techniques.
SAS is no longer focussing on pharma and has shifted the priority into other industries such as finance.
R offers various benefits, including cost savings, innovative methods, universities shifting towards R, simpler/cheaper training due to its open-source approach, and much more.
More statisticians are considering transitioning from SAS to R; The Effective Statistician Academy offers a course designed for this purpose.
Learning R is not meant to replace SAS but supplement it (at least for the mid-term)
Do not limit yourself to SAS only. Take the initiative to learn R and its advantages to enhance your skillset and knowledge.
Learning R may seem daunting at first, but with the right guidance, and through The Effective Statistician Academy, you can effectively transition from SAS to R, expanding your skills and knowledge, and ultimately boosting your career.
A new course explaining how simulations can improve study design and data decision-making.
The course outline.
Benefit of honing simulation skills for all statisticians, both early-phase and late-phase trials, in order to provide more accurate advice to colleagues, and more!
The benefits of simulations include improved protocol development, sample size determination, and data analysis planning. Kim and Jamie's new course, "Mastering Study Design and Strategy with Simulations," offers a comprehensive guide to using simulations in study design and is available from July 2023. By improving their simulation skills, statisticians can provide valuable insights to their colleagues, resulting in better-designed trials and more efficient data analysis.
Share this episode with your friends and colleagues now!
Brown's "Dare to Lead" emphasizes the importance of cultivating courage and bravery in leaders
Embracing vulnerability,
Being true to values
Setting boundaries
Knowing and understanding their “why”
Asking for help
Holding oneself accountable
Empathy
Brené Brown's "Dare to Lead" offers practical advice and research-backed evidence to help leaders develop trust with others through empathy and vulnerability. Through Marius' PSI Book Club review, statisticians could delve deeper into the book, have rich discussions, and apply its principles in the work environment. Emotional connection, accountability, and empathy are just some of the many essential tools leaders might utilize to create a more positive work environment. Ultimately, cultivating these leadership skills can benefit the whole team and lead to better experiences for both employees and employers alike.
So listen to this episode now and share this with your friends and colleagues!
The exclusive access to networking, training, and career advancement opportunities.
Its next-level recruitment process by introducing its 'Active Talent Selection' approach, which ensures that candidates are connected with the right employers.
The pre-evaluation process.
Clivoffective has revolutionized recruitment in the statistics market. With Clivoffective at the forefront of recruitment in the statistics market, the future looks bright for candidates and employers alike.
Listen to this episode now and share this with your friends and colleagues who are looking for opportunities!
Click here to learn more about Clivoffective and join the network: Clivoffective
A statistician should act as a detective by asking questions to uncover what is really being asked of them and navigating uncertain spaces to reach conclusions.
When acting as a lawyer, statisticians must keep in mind who their audience is in order to present information effectively.
A statistician should act as a journalist that understands how evidence is used down the line, such as when presenting figures or tables to clients or stakeholders.
Being a killer statistician is not just about number crunching and data analysis. It is about adopting multiple roles to uncover insights, communicate effectively, and ensure real-world impact. Developing these skills requires a combination of methodological proficiency, curiosity, and awareness of the context and audience. By following Debarshi's advice and curating role models, we as statisticians can become successful and impactful.
Listen to this episode now and share this with your friends and colleagues who can learn from this!
Perfectionism can lead to career failure due to a fear of judgement, or low self-esteem.
Procrastination can be caused by an unclear next step, or a task taking too long.
Being too busy often leads to stress and an inability to invest in personal development.
Fear of failure or rejection can prevent exposure and impede career progression.
Missing inspiration or passion reduces motivation and the ability to influence others.
By recognizing these five reasons for career failure – perfectionism, procrastination, being too busy, fear of failure or rejection, and lack of inspiration or passion – you will be better equipped to tackle them head-on and achieve your goals. Remember, a successful career is not just about hard work; it’s also about self-awareness, personal growth, and a willingness to take risks.
Share this link with your friends and colleagues who can learn from this!
The Academy offers a range of training courses in four distinct areas: Leadership, Innovation, Knowledge and Excellence.
Courses are taught by experts in their respective fields and cover topics such as Estimands, Simulation, Data Visualization and Digital Health Applications.
Training is both affordable and easily accessible with content split into digestible chunks for maximum convenience.
Listen to the episode now to learn more about the conference and share this link with your friends and colleagues!
What are the key elements to building trust with coworkers and supervisors as a statistician
What role does setting expectations and abiding by specific timelines play in the success of a project as a statistician?
How can the use of creative data visualizations such as animated scatter plots offer a different perspective on data beyond traditional line graphs and bar charts as a statistician?
Some experiences where data visualizations are demonstrated to an advisory board and evoked a "wow" effect for their surprising quality as a statistician
Why is data visualization especially effective in communicating complex ideas in a manner that non-statisticians can understand as a statistician?
How can investing in data visuals help one stand out and over-deliver expectations in certain cases, potentially leading to promotions as a statistician?
Details to provide about your interactive workshops on data visualization that you present both online and in person as a statistician?
How to Avoid Bad Quality from Programmers and Data Management
How can statisticians, programmers, and data managers work together to develop quality products quickly?
What measures can we take to ensure that everyone involved has an understanding of the project's goals and processes?
How we can strike a balance between rigorous processes and trusting individuals to make decisions without cutting corners?
What strategies we can implement in order to ensure effective communication between all parties involved in a project?
In the event of mistakes or setbacks, how can postmortems and lessons learned meetings help to resolve issues with lasting solutions rather than pointing fingers?
Listen to this episode and share with your friends and colleagues!
What can statisticians and data scientists learn by exploring the early development research questions?
Are there any unique design challenges that they should be aware of?
How can Bayesian approaches offer new insights that traditional methods cannot provide?
What strategies should data scientists employ in order to successfully navigate the complexities of these new approaches?
What knowledge gaps exist regarding the implementation of these new analytical techniques, and how can statisticians and data scientists bridge them in order to maximize their effectiveness?
These are all important questions for statistical and data science practitioners, and exploring them further could reveal opportunities for novel ways to approach problems in an increasingly complex field. So, share this link with your colleagues!
Why is it impossible to have a great standard data visualization?
Are you seeing a return to single arm studies from an HTA perspective?
What potential drawbacks should be considered when opting for non-randomized comparative trials instead of randomized control ones?
If a full RCT isn't feasible, what other viable approaches are available as substitutes?
How can sponsors best communicate their research with HTAs on these alternative solutions and explain the value they present in comparison to an RTC design study?
Listen to this episode and share them with your friends and colleagues!
Making sure that your research is reproducible is important in the pharma industry because it allows others to understand what you have done and how you arrived at those conclusions. By following these three steps—documenting everything, creating reusable code, and sharing results—you will be able to make sure that your research is reproducible for anyone who needs access to it now or in the future!
The EU HTA will not only affect all statisticians in the pharmaceutical industry with respect to skill sets and collaboration (we talked about that in podcast #3), but will also have an impact on the economic modeling that is needed for the reimbursement and pricing decisions in many European countries. Understanding the influence of the joint clinical assessment on economic modeling, the relationship between estimands and PICOs as well as the pre-specification of statistical analyses and their use in economic modeling is becoming much more important for statisticians in the near future.
In this episode, we will talk about the role of economic modeling in the HTA process, and the influence of the EU HTA, and the corresponding statistical analyses on that process.
Future implications of EU HTA and how Next Gen get involved
Interview with Katrin Kupas and Dr. Arthur Allignol
All statisticians in the Pharmaceutical Industry will be impacted by the new EU HTA regulation. Activities around HTA submissions will happen earlier than currently, in parallel to the regulatory approval process for marketing authorization. There will be an increased scope of evidence for the joint clinical assessment to fulfill the needs of all EU member states, and so there will be a large package of statistical analyses that need to be provided in addition to the submission to the regulatory bodies.
This will redefine how you, as a statistician, work, and with whom you need to collaborate. Both HTA and clinical development statisticians will need to join forces to define the value story for the complete lifecycle of the drug. HTA specific analyses will need to be planned in parallel with clinical development.
In this episode, we will discuss the future skill sets that statisticians in the pharmaceutical industry need to adopt with the new EU HTA regulation being applied in 2025 already.
The Recent Alzheimer Story - an absolute low for the industry and especially for statisticians
Interview with Dr. Arthur Allignol and Anders Gorst Rasmussen
If you’re a statistician working in a regulatory setting, you’re probably familiar with estimands as a way to frame the clinical question of interest. But what’s the role of estimands beyond regulatory approval, in a Health Technology Assessment setting? That question is especially important these days where the framework for pan-European HTA is taking shape. In this episode, we’ll touch on some HTA body views around estimands, and reflect on how current draft guidelines for EU HTA do and don’t address estimands.
The first conference of The Effective Statistician
The conference is free to attend and will be five hours long, with a variety of presentations ranging from 15-20 minutes each.
Some of the topics that will be covered include estimands, bayesian approaches in early development, medical affairs, digital health applications, study program simulation, influencing skills, and data visualization.
Antonia Morga, Nicholas R. Latimer, Martin Scott, Neil Hawkins, Michael Schlichting, Jixian Wang, Is Intention to Treat Still the Gold Standard or Should Health Technology Assessment Agencies Embrace a Broader Estimands Framework?: Insights and Perspectives From the National Institute for Health and Care Excellence and Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E9 (R1) Addendum. Value in Health. S1098-3015(22)02148-9. doi: 10.1016/j.jval.2022.08.008.
What is the ASAP and what you should know about it
The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule).
Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potential risks associated with a drug or vaccine.
In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting.
This process will develop a better understanding of the safety profile of drugs and ensure that patients' safety is well-thought-of.
Statisticians are trained to be leaders and have many of the skills required for leadership positions
Statisticians can use their problem-solving, questioning, and decision-making skills to help resolve issues within an organisation
An example of how a statistician's leadership skill can be used when there is a case in manufacturing and how looking at data from all stages of production helped identify where the problem was occurring so it could be fixed
Do not underestimate the leadership skill set statisticians have - you may be able to influence and lead projects more than you think!
First Mover Advantage gives the statistician the power to direct development and growth in relation to the creation of new solutions to problems that arise in the beginning and even in the third phase of the research before they are released for actual application by pharma companies.
The consideration of the first mover advantage requires that a statistician be more detailed in checking the data and using such advantage to offer a more effective solution to existing issues.
There is a need to start up early in determining the problem and communicating it with others.
For a person to take the first mover advantage, there is a need to speak out. It takes courage to do so, but with the right confidence and the right motivation, reaching out to the audience is easier and more effective for statisticians to consider.
Listen to this episode, you would be able to get the best value you can apply in your own profession as a statistician and as a leader in the industry.
By country analyses for clinical trials and observational studies
Finding a common ground among the countries involved and using it to establish the foundation of the study.
Using the common ground as a basis for the variables that are to be used for sample measurement and analysis.
Improving how data is balanced between differences to create a singular and focused outcome.
Considering removing countries that do not fit within the common ground variable in a multi-country study.
It is expected that the lessons presented in this episode will help statisticians pay more serious attention to the differences in their base sample source to reduce the margin of mistakes once the data is already being analyzed.
Listen to this episode now to see how this information could personally and professionally help your journey in statistics.
Leadership - what it means, how we built it, how it will help us shape the future of statistics
Developing rapport with the audience is critical to convincing them that your message is something they can use.
Storytelling does not need to be in depth, but it needs to be connected with the topic that you are going to discuss in the presentation.
Storytelling enhances the way you connect with your audience through giving them an idea of what you have done and inspiring them the fact that they can achieve the same success that you have.
Storytelling takes different strategies depending on the topic being discussed in a presentation.
Listen to this podcast and learn more about how you can use storytelling to get the attention of your audience and send a message that triggers action and change.
Here are some lessons you can get from this conversation:
You need to frame your data and measure the success of your product or your studies and protect the information to avoid any exploitation by other third parties that would want to use your data for their branding.
Establish an effective manner by which you compare your data with the data collected by your competition.
Make sure to react fast and have an existing alternative communication plan in case exploitation of data does happen.
The landscape of meta-analysis continues to change depending on market demands and it is critical for statisticians to consider these adjustments to follow through the changing trend.
Head on to The Effective Statistician and learn more from what this podcast offers. Please share this with your friends and peers and learn from our conversation.
Bonus Episode: Understanding leadership deeply – trust, relationship, and influence for statisticians
Using the R Strategy to improve the way teams work towards a singular focused goal.
Improving how teams are directed and delegated in tasks where they can perform best.
Using internal leadership alignment to help key persons become more effective in their assigned posts.
Head on to the podcast, listen to our conversation, learn more about effective developments in informatics and how they change the culture of statistics.
Share this with your peers and we hope to give you inspiration as we gear ourselves towards more efficient modern statistical developments now and in the future for better data utilization.
RWES are collected through statisticians actually getting involved in the collection of data through interview, survey, and feedback questionnaire from both physicians and patients.
Validation of data should be accomplished through focusing on the accuracy of the representation of the data from actual settings and how they could be applied in real-life cases.
Statistical reliability is critical to the value of clinical trials and how they could be applied in actual life situations and health cases.
Proving to FDA that RWEs are valid enough to provide the support needed by targeted patients is critical to determining the real value that every clinical trial serve.
Listen to this episode and share this with your friends and colleagues!
Bonus Episode: Impactful influencing: actionable advice to get things done through and with others
Is influencing actually something bad on inappropriate?
What characterizes an influential person?
Which practices help statisticians increase their influence?
Many statisticians are more introverted. How can they deal with more extrovert business partners from other functions?
Relationships are key for influencing without authority. Trust is key to building these relationships. What can statisticians do, to generate more trust?
Networking is another aspect of building relationships. What actions to take to build networks?
Many of us work in virtual settings to some extent. This poses additional barriers to influencing others as it is much harder to be heard and understood. Which techniques can we apply to overcome these hurdles?
Statisticians’ contributions to change is increases when they get involved with smaller crowds.
Statisticians working with smaller groups or agencies are required to develop better communication skills so they can easily collaborate with their teams and their superiors and actually drive goals towards extensive developments.
Effective leadership is a must for statisticians who become a part of smaller entities because they get involved in decision-making procedures more actively.
Statisticians who want to transfer from larger entities to smaller ones should be prepared to take on distinct huge responsibilities.
Listen to this episode and share this with your friends and colleagues!
As a statistician – do you take the back seat or do you drive yourself?
RWEs are dependent on actual patient reaction and response data collected through records provided by the healthcare agencies
RWEs are viewed differently by statisticians and the FDA which may create friction, especially in the process of having one medication submitted for approval and production.
and more...
Learn more about effective clinical trials based on dependable evidence and other topics that will help you in becoming an effective statistician. Listen to this episode and share this with your friends and colleagues!
Patient adherence is affected by different surrounding factors in the lifestyle and personal perspectives of the patients involved in a clinical trial
Technological innovation makes it easier for patient adherence to progress; however, implementing these technological inclusions may present challenges to researchers.
Hearing the voice of the patients is critical to determining strategies that can help improve patient adherence in clinical studies.
Patient-centered goals could drive patient adherence to increase fast especially because the participants the benefits that they can get from strictly following the schedule and dosage of their medication.
Addressing personal fears and barriers through proper communication with the patients is an important aspect of successful clinical trials. It can only be achieved through the involvement of personally invested researchers who are more than willing to reach out to the participants and hear out their concerns.
To be a better statistician, learning how to influence patient adherence positively can help improve not only your capacity to reach your goals but also your capacity to motivate the implementation of change in different fields of healthcare.
What are you good at? What are you passionate about? What can you do to add value to the society?
Statisticians have all the necessary skills to make things happen and they should try to find an option to make such changes happen by standing up and getting out of the office to engage with people and organizations that relate closely with their passion.
Working on your passion entails working more on value. For statisticians who want to gain more satisfaction from what they do, stepping out of their comfort zone may be a great choice to consider.
From connecting with different networks and meeting other advocates, the skills and knowledge of a statistician can be used further when the goal is more focused on a creating a specific solution to improve patient-care.
To make that choice of stepping out of statistics, you must weigh your odds, find your passion, connect with the right network, and be motivated enough to make the change you want to achieve.
Leaders never stop learning even from their subordinates
Leaders invest in themselves in sharpening their tools, their skills and exploring possibilities for growth
Leaders get along with change and move forward by adjusting to the demands surrounding their profession.
Leaders thrive in finding more solutions in the face of limitations and barriers and pursuing the goals they have set for themselves and their team.
Perseverance differentiates the pathway of great leaders from good leaders.
Clarity of purpose redefines the way a leader establishes his plan and how he pursues to reach his goals even when situations change.
Learn more about leadership that will help you in becoming an effective statistician. Listen to this episode and share this with your friends and colleagues!
Some of the input data is missing for some studies. How do you deal with these missings - just exclude them?
You compare many treatments with each other in a pairwise way. How do you best communicate this large matrix of pairwise comparisons?
You need to adapt your NMA last minute because there was a delay in the system and your systematic literature search became outdated. Do you need to postpone the launch of the new product by a couple of weeks?
You got regulatory approval for a new indication earlier than expected. While the regulatory team celebrates the achievement you worry that you need to have your NMA ready 3 months earlier. Will you be able to deliver?
We discuss these and many more problems of NMAs.
If you would like to get help around these, write an email to [email protected] or contact me via LinkedIn.
Listen to this webinar while Emma and I talk about exploring the resulting recruitment challenges in a post-pandemic world within Life Sciences as a sector, also specifically within statistics across the UK and Europe. We confront recruitment challenges, as well as taking a thorough analysis into what Statisticians want—how to hire and how to keep top talent.
The best sources for RWE that you may never heard about
What brought Anders into RWE
What makes Nordic countries special when it comes to health system?
What are some key success factors of the Nordic health system?
What kind of population registers are there?
and more…
Learn the fundamentals of preparing and delivering an engaging, impactful presentation including the five questions you need to answer for ANY presentation (and the one you should avoid)
Understand the three keys to creating powerful, clear visuals and be aware of the most common mistakes
Hear real industry examples and experiences that demonstrate and reinforce key presentation and visualization concepts
Improve one of your own presentations (past or current) that will serve as an application of these tools and concepts
Stay tuned while Andrew and I talk about the following:
What is extrapolation?
What are source and target populations?
The guidance states: “Where possible, quantitative methods should be used for the collation of available data and the investigation of potential modifiers of the treatment effect”. How could such quantitative methods look like?
What are the major challenges?
How to integrate external data into your clinical studies: from theory to application
This is a series of episodes and today's content is the first episode. Join Jenny and I while we dive into her career and discuss important points about the following:
What is Launch and Lifecycle
How as it evolved in the last 2 decades with respect to
Phase IV studies
Observational studies
RWE
HTA
Global vs local positions
What is the relationship between HTA vs non-HTA areas and collaboration with stakeholders
Collaboration with the regulatory side
Involvement in strategic evidence generation
Number of statisticians/programmers supporting this area
Organization within or outside of statistics departments
In this episode, Liane Davey, who is the author of the book "The Good Fight", and I will be discussing about how to say no effectively. I met her on Linkedin and we had a couple of messages and it was just really cool that we think the same way. Stay tuned because you'll surely love it!
How using Altmetric and Dimensions data, links can be identified and groups of the influential leaders in different research spheres can be discovered?
When diving into the research landscape of a particular Therapeutic Area or clinical research focus, getting the low down on who is authoring with whom, and who is ‘leading the pack’, is crucial?
How having this kind of insight into the dissemination and ‘journey’ of research provides ‘organizational wisdom’ that can enhance foresight, competitor analysis or benchmarking and importantly, inform outreach and publication strategies?
Join Sam and I while we talk about the following advice on how to start the week right:
Don't dive directly into meetings or emails
Review your annual goals
Review your achievements from last week
Start/stop/change/continue
Review existing to-dos and open-loops
Review the upcoming week's events
Plan your weekly big 3
Clean up your calendar
Plan your daily big events
What things that can wait
Have an invite in your calendar with these steps to create a routine or use the full focus planner
References:
This is your life! This is an older podcast by Michael Hyatt in which he talks a lot about these topics. He has also some new podcasts which you can find here: https://fullfocus.co/
Join our discussion today as Thomas and I talk about this.
Key references:
Debray TPA, Moons KGM, van Valkenhoef G, Efthimiou O, Hummel N, Groenwold RHH, et al. Get real in individual participant data (IPD) meta-analysis: a review of the methodology. Res Synth Methods. 2015 Aug 19;6:239–309.
Debray TPA, Riley R, Rovers M, Reitsma JB, Moons K, on behalf of the Cochrane IPD Meta-analysis Methods group. Individual Participant Data (IPD) Meta- analyses of Diagnostic and Prognostic Modeling Studies: Guidance on Their Use. PLoS Med. 2015;12(10):e1001886.
Debray TP, Schuit E, Efthimiou O, Reitsma JB, Ioannidis JP, Salanti G, et al. An overview of methods for network meta-analysis using individual participant data: when do benefits arise? Stat Methods Med Res. 2018;7(5):1351–64.
Nguyen T-L, Debray TPA. The use of prognostic scores for causal inference with general treatment regimes. Stat Med. 2019 Jan 16;38:2013–29.
Sarri G, Patorno E, Yuan H, Guo J (Jeff), Bennett D, Wen X, et al. Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making. BMJ EBM. 2020 Dec 9;bmjebm-2020-111493.
Listen to this episode and share this with your friends and colleagues!
10 reasons to submit a poster for the PSI conference!
During my early years, I was overwhelmed by so many trainings, SOPs, and processes. Only after my later years I learned what quality is really about. Gary fundamentally helped me and many others have a very different and more insightful/helpful/easy perspective about this topic.
Listen and learn while we talk about the following points:
During your first years in the industry - how did you think about quality? What did it mean to you?
What are the key parts of quality today for you?
How does this understanding of quality differ from being compliant to SOPs?
Have you seen an example where a person was compliant to SOPs but didn't deliver quality?
How can we increase quality as defined in this episode in our organization?
Today, I am interviewing Dacheng Liu from Boehringer-Ingelheim and talk about the different opportunities open for data scientists in the pharmaceutical industry and answer the different interesting points below:
How did you get into data science and what does "data science" mean to you?
What are typical data science methods that we are not yet using enough?
Which areas do you think, have currently the biggest potential to benefit from such methods?
Which case studies do you have in mind?
Which areas will become important in the future in terms of data science?
Over the last years, leaders of statistical organisations across Europe are meeting each year to talk about how the community can be moved forward and other important topics affecting statisticians in the industry. In 2021 was another meeting and I'm talking with Chrissie Fletcher about some of the topics covered during this years meeting. Specifically we talk about:
What has happened in the last 2 years in terms of career development and leadership skills and what will come in the future?
Data Science vs biostatistics?
Which are the areas typical clinical statisticians can learn from data scientists?
Chrissie has an awesome personality. She has a lot of influence in the stats community and she has done lots of different presentations and is actively participating in different organizations. You will surely learn much more about the topics from the stats leadership meeting which is really relevant for you.
Listen to this interesting episode and learn a lot. Share this with your friends and colleagues!
Why and how to show individual patients in your charts
In our standard graphics, we usually present summary statistics only. The exception is the Kaplan-Meier plot showing also individual patients. Showing individual patients effectively tells us so much more about e.g. clusters, outliers, and extreme values. Join Benjamin and I while we dive deep into the following points:
Show uncertainty
Show actual number of patients
Give a feeling for the evidence
Connect to the physicians seeing the individual patients
Increase transparency
How to create:
Spaghetti plot
Slope graph
Using jittering for categorical data or thickness based on numbers of patients
Interview with Paul Terrill
Do you think, you have nothing to add to a statistical conference? Are you afraid of sharing your achievements?
Do you wonder, why you should put in the effort on top of your day-to-day job?
All these thoughts and questions will be addressed in this episode with Paul Terrill, the chair of the scientific committee of PSI.
Beyond the questions above, we will also talk about the logistics and practical tips on how to submit your abstract and to become a speaker at next years conference.
Interview with Roger Hoerl, Ron Snee, and Geoff Vining
In today's episode, Sam Gardner together with Roger, Ron, and Geoff will dive deep into Statistical Engineering and will discuss about the following points:
Definition of Statistical Engineering (SE)
How did the idea of Statistical Engineering come about
Examples of what SE
Examples of where it has been applied and if it's gaining traction
Is SE an idea and a practice, or is it a profession, or both?
How does SE compare to the role/profession of “statistician” and/or “data scientist”
Does SE apply to statisticians working in pharmaceuticals, other Industries, or Government?
The answer comes with the buffer in the system. We always have disturbances in terms of unplanned events in complex systems - like the German trains. If there isn’t enough buffer built in, these minor problems lead to a break-down as the system cannot adjust. Consecutive problems eat up the little buffer and delays accumulate.
Listen to this episode to learn about ways to build in buffer!
How I'm training others in improving their visualization skills
Listen while Ena and I discuss how to improve one's career and how to make good choices that help you become more effective and have more impact at work.
How Ena started
What are the statistical unicorns
How to become a better communicator
Sharing of experience about an important presentation
It is important to be an effective negotiator as negotiation is all around us all the time. Whether it's about daily life or making decisions at work as statisticians. But at as experts in this field (and being mostly introverts), we need several skills to develop and grow our negotiation skills.
Today, I talk with Lousin Mehrabi who is a negotiation expert. Join us while we talk about the following points:
In this episode we focus on how you can grow in your effectiveness as scientists and leaders. With that in mind, we like to dive into this concept of Dark Data and how, where, when, why this impacts decision making in the pharmaceutical industry.
How dark data is an issue in the area of healthcare, particularly pharmaceutical R&D, clinical trials, manufacturing, marketing, and health technology assessments?
What's the taxonomy of dark data?
Where might statisticians/data scientists have their own “blind spots” related to dark data?
From the standpoint of “effectiveness”, what is Davids advice to statisticians when it comes to this matter of Dark Data?
She is a data designer specialized in visualizing information in understandable and meaningful ways. She works as a Visualization Lead at UCB since February 2021. Before her current role, she worked at BBC News, where she was part of the UX&Design and the Data Journalism teams, and at the MIT SENSEable City Lab. She has also collaborated with other media and advertising organizations in Spain.
In 2017, she gave Data Visualization classes at the MIT School of Architecture. One year later, she designed the didactic program Communicating with Data that MIT developed for the Dubai Institute of Design and Innovation.
She graduated from the MFA Information Design and Visual Communication at Northeastern University. Her work has been recognized in the Kantar Information is Beautiful Awards and the WAN-IFRA European Digital Media Award.
Listen to this episode and share this with your friends and colleagues!
Strategy is a buzz word that is all around. Everybody talks about it but I didn't know what it is for a very long time. I recently read a nice book about this and in this episode, you'll gain knowledge about what I have learned from this book.
What is a strategy?
Diagnosis of the problem “What is going on here?”
Strategic pillars - guiding policy
Tactical plan of coherent actions
But there is a lot of bad strategy around:
Fluff - just lots of buzz words
Failure to face or define the challenge
Mistake goals for strategy
Bad strategic objectives in a sense of not addressing critical issues or are impracticable
- A conversational podcast to address the non-technical challenges in data and information management, learn from the experts, and establish a framework to reason about information in a business context.
Listen to this episode and share this with your friends and colleagues.
Posters, flyers, papers and how you can use QR codes to enhance them
Join us while Irene and I talk about how animations and movements can create a lot of advantages such as the following:
Portray data directly through motion (what Irene defines as ‘data as motion’). This is an example of it.
Interpolate through data values (‘motion as an interpolation of data values’). Gapminder, or the visualizations showing how PASI changes through time under different psoriasis treatments (see paper here).
Guide viewers through the visualization (‘motion as a storytelling device’). Like in this visualization where every time the user interacts a transition happens.
And captivate viewers (‘motion as a captivator’). All the examples mentioned above fit in this category.
Listen to this episode while we also I discuss this interesting book entitled Ich arbeite in einem Irrenhaus or I work in a mad house (in English) which can help us be happier at work.
From feelings to understanding: Verbalize your feelings. What is stupid or bad about your company? Go into the details and don’t stop with generic statements.
From negative to positive: Don’t focus only on the negative things. What are all the great things? Colleagues, environment, perks, interesting projects. What would you love to do more. Does your supervisor know about it?
Determine the trade-offs and decide: What’s on the positive side and what’s on the negative side. What are the weights? How bad or positive is it? Is the grass on the other site really more green? Consciously make a decision to stay, improve, change or leave.
Join us while we talk about this practical guide which has ten effective principles—counterintuitive tactics and strategies—you too can use to become more persuasive in both your professional and personal life:
How to become the smartest person in any room
How to quickly establish rapport
How to create trust with tactical empathy
How to generate momentum and make it safe to reveal the real stakes
How to gain the permission to persuade
How to share what is fair
How to calibrate questions to transform conflict into collaboration
How to spot liars and ensure follow-through from everyone else
How to get your price
How to create breakthroughs by revealing the unknown unknowns
Leadership is multidimensional. It depends on lots of different skills like communication, being a good team player, building trust and relationship, negotiating conflicts, and more. The kind of leadership that I am talking about is not supervising other people or the administrative type of leadership, but it's a type of cross functional influencing where you lead others that don't necessarily report to you.
To simplify it, we have developed these 5 levels of statistical leadership:
Implementer - I do what you tell me
Analyser - Tell me what you want to analyse and I will suggest analysis and implement them
Consultant - I understand your problem and I advise you what the team should do
Leader - I understand your problem and I convince you what we should do
Entrepreneur - I deeply understand the business and I foresee the changes in the business. I build an environment in which statistical leaders grow.
Listen to this insightful episode and share this with your friends and colleagues who might learn from it!
Non-clinical statistics for research and development
Statisticians support more than just clinical trials in R&D. Some non-clinical areas where statisticians contribute to drug development include:
Discovery
High throughout screening of drug candidates
Genomics
Early Phase
Safety studies (animals)
Animal models for efficacy
In-vitro Analytical methods to predict in-vivo performance
Mid-late phase
Determining manufacturing process targets for clinical trial material (process definition)
Determining the best formulation for a drug product
Developing robust and accurate analytical methods to assess the quality of the drug substance and drug product
Assessing the stability of the drug product
Determining the full manufacturing process and the control strategy to ensure high quality (process characterization), including
Operating Ranges
Determining Critical Process Parameters
Developing quality specifications for inputs (drug substance, raw materials) and outputs (drug product specifications)
There are other areas that statisticians can contribute in non-clinical R&D.... basically anywhere you need to generate and evaluate data in R&D, you can find an application of statistics.
Listen to this episode and share this with your friends and colleageus!
Join us while I talk about this topic with Sam and dive deeper into these points:
Non-clinical statistics is the application of statistics in pharmaceutical R&D and manufacturing and that is not directly related to planning and analyzing clinical trials.
There are numerous statistical issues to deal with in these areas, and often regulatory expectations require the use of statistical methods.
In this episode we discussed example areas for Non-Clinical Statistics in the Manufacturing and Quality area (also known as Chemistry, Manufacturing and Controls (CM&C))
Analytical Methods for assessing quality
Understanding the science and technology is important (understanding how the data is actually generated or "how data happens").
Determining appropriate specifications for a drug product and ensuring that the natural variation in the measurements will not lead to failing specifications.
Qualifying and determining the defined content of chemical reference standards (using appropriate experimental designs)
Ongoing Manufacturing Processes
Using control charts for on-going monitoring of manufacturing processes
Understanding sources of variability that impact the output of the manufacturing process
When something goes wrong: for example there is a bad batch that fails to meet its quality specification, and when this happen, an investigation has to be conducted, and statistical thinking, data gathering and combining, data visualization, data mining and experimental design can be used as part of the investigation
Building tools to automatically build data sets from manufacturing data and visualize that data
The Wonderful Wednesday Webinar series was introduced in an earlier episode. In this episode we dive deep into what has happened over 1 year of the Wonderful Wednesday Webinars. This great series on visual analytics helped us to learn how we can use visualizations of data in our development process and beyond. Bodo as the new chair and Steve as an early member are talking with me about this initiative of the EFSPI/PSI Visualisation special interest group.
Join us while we discuss the following points:
What have you learned about data visualization in the last year from the WWW?
What was your favorite visualization and why?
What makes this webinar series special for you?
What would you recommend to someone wanting to take part?
Let's welcome Sam Gardner as our new co-host for our podcast show! In his first episode as a co-host, we spend some time getting to know more about him while he answers the questions below:
How did he learn about this podcast and get connected to it?
Why is he on the podcast & what are his plans for future collaboration?
What is your educational background?
Where has he worked, what kind of work has he done in the past?
What is he currently doing now?
Outside work, what does he like to do?
Listen to this episode and share this with your friends and colleagues!
He has invested an enormous amount of time to leverage simulations for understanding the designs of studies and development programs. In this episode, I discuss the following questions with him:
Why is trial simulation necessary?
What design features do you assess?
How do you get a good stability in terms of the simulation precision?
Where are the limitations to these simulations?
What are his experiences in communicating the outcomes of the simulation?
How he thinks simulating studies or development programs will look like in 5 years?
We designed this program for statisticians and data scientist to strengthen your leadership skills so you can maximize your impact at work even if you don’t have direct reports.
The Effective Statistician Leadership Program, a modular program of self-learning parts and moderated small group discussions, helps all statisticians and data scientists. It especially takes into account the needs of pharmaceutical statisticians, but the concepts will apply to any data scientist.
It aims at all levels of statisticians and helps both junior statisticians without management responsibilities and experienced statisticians leading teams. We believe all data scientists and statisticians can be leaders.
Join us while we discuss these questions with David and learn more about the following points:
How did David get to this position as a biostatistician at a CRO?
How is it made sure that information from the DMC stays within the DMC?
What is David's most challenging and most exciting experience he had while working in a DMC setting?
When working on open-label trials, it is sometimes requested to “artificially” blind the date but have a DMC review the unblinded data. Has he come across these settings as well, and what’s the challenge he sees here?
However, we know that there are thousands of ‘unsung heroes’ around the world, working in different capacities on different clinical trials to make the breakthrough. It has been a herculean collective effort. Of course, while this is a particularly high stakes situation, seeing an impact on patients’ lives motivates us no matter the therapeutic area. In this podcast, I interview Nancy Carpenter, a Principal Statistician at Veramed who has worked extensively on COVID-19 trials over the last several months. Our wide-ranging discussion covers:
Her experience of working on COVID-19 trials
How patient stories inspire her
How we balance risks and manage the impact of COVID-19 on other clinical trials
How a role in pharma provides meaning and fulfilment
How the pandemic has increased public interest in the pharmaceutical industry
Listen to this episode now and share this to your friends and colleagues!
5 steps to present successfully to upper management about complex stats (and everything else)!
Thus, I'm thrilled to talk with Swarna Khare about this topic. Swarna is a long-term listener of the effective statistician and today, it is a great opportunity for her to share with us the ways to think and act more strategic.
We answer the following important points:
The role of the branding of statistics and how it led Swarna to change from statistics into RWE?
What does “working strategically” means for her?
What did she do to prepare for this change?
What she learned after the switch to RWE?
What she recommends to statisticians to become more involved in strategic discussions?
Listen to this interesting episode and share this with your friends!
Interestingly, the visualization of uncertainty - one of the primary forms we use to communicate it - is a rather unknown field. In this episode, I'm very excited to speak with Paolo Eusebi, who has done research in this field to answer the following questions:
What can we learn from examples outside of medical research? How is it explained to the general public?
What’s the current status in medical research?
How can we become better in communication of uncertainty?
What are further excellent resources regarding the display uncertainty?
So today, I'm glad I have a great colleague with me who is an expert on change management and has helped me a lot to drive changes within a big organization.
Listen to this episode and learn the following points:
As part of his master thesis, he worked on an idea; I had sketched out a couple of years ago but never had the time to fully think through. I wanted to explore how we could utilize existing study data to inform the benefit-risk assessment of different therapies. In this episode, you will learn a new concept which also is related to minimal clinical meaningful differences and helps to assess the impact of various adverse events on the patient. Specifically, we dive into:
What is the benefit-risk tolerability measure?
How can we use the information on which patient discontinue to inform the benefit-risk assessment?
How does the model help us rank adverse events in order of their importance?
Which adverse events cannot be classified with the model?
How to use the model to inform relevant difference for efficacy endpoints?
Listen to this episode and share it with your friends and colleagues!
What we can learn from Taylor Swift about creating data visualizations
Join us in today's episode as we are talking about the following points:
Lyric
Answer
Question
"Cherry lips, crystal skies I could show you incredible things."
Taylor talks of her mastery of colour, as she alludes to the incredible insights she can display through just a splash of red against a crystal-clear background.
What are your key learnings regarding colour?
"Find out what you want Be that girl for a month."
Unlike many data projects, Taylor's will succeed - because she takes the time to find out what her stakeholders want, and agrees clear deadlines.
How does your practice look like to learn about the needs of the stakeholders?
"So it's gonna be forever or it's gonna go down in flames."
Unlike many data projects, Taylor's will succeed - because she takes the time to find out what her stakeholders want, and agrees clear deadlines.
How does your practice look like to learn about the needs of the stakeholders?
"But I've got a blank space, baby And I'll write your name."
Taylor's only mistake. My advice would be to leave that space blank and clutter free.
How do you measure the success of your visualization?
In today's episode, I am sharing about my experience I had earlier in my career when I was working on a lot of different publications with different physicians who were responsible with these studies.
Listen to this episode and share this with your friends and colleagues who can learn from it!
You will see from our discussion the AHA moments Stuart had by reading this book and the important points I've learned. Here are a few, we dive in more deeply:
How to be good in negotiation
Separate the people from the problem
Focus on interests, not positions
Work together to create opinions that will satisfy both parties
Negotiate successfully with people who are more powerful, refuse to play by the rules, and/or resort to “dirty tricks”
Listen to this episode now and share it with your friends and colleagues!
Feeling overwhelmed? Learn the best tricks and the real big levers
It seems to be the curse of our time. Being busy. Being overwhelmed. Not reaching our goals. Feeling bad about working too long and not spending enough time with our loved ones or for other relevant activities like sports and meeting friends.
I often get asked about how I can get all these things done. Having a great career with consistent promotions, growing a team in a new company, being active for the community as a PSI board member and leading the communication committee, running a weekly podcast, being active on social media like LinkedIn, creating online courses for improving leadership skills for statisticians and data scientists. And last but certainly not least being a father of 3 kids and a husband.
I surely apply some productivity tricks and I will talk about these in the webinar, but the real big levers are not found in the usual productivity books. They have nothing to do with getting more done in less time. The key is to get the right things done in the right way.
But what are the right things? What is the right way?
Sign-up for the upcoming webinar to learn about how you can identify the right things and then get these done in the right way.
September 29th or October 1st at 4pm Central European Time/10am Eastern Summer Time.
Being brilliant at stats is really important, but it is not the only thing one must be good at. In this episode, I talk about my good and bad experiences and discuss what we can learn from them. I also discuss the following points:
What you must do if you are:
Not being understood
Working on irrelevant things
Getting into big arguments and losing them
Not being able to appropriately pushing back
Getting a bad reputation
Getting a bad rating
Becoming frustrated and unmotivated
The solution for many of these topics is becoming a better leader - not as a supervisor but as a leader without a title. So in summary, balance your investment into methodological skills with developing your leadership skills.
Listen to this episode now and share this with your friends and colleagues!
These kinds of visualization helped me a lot to open new doors and made me amazingly easy to stand out from other statisticians. In this episode, I am sharing the following points:
Visualization help you sell your work
Easily understandable
Easy to stand out
Is fun to create
Lots of opportunities beyond our usual graphs
Showing the variability
Showing the individual patients
Scatterplots
Line graphs
Heatmaps
Cumulative distribution functions
Histograms or fitted density functions
Animations to show changes over time
Interactivity to showcase subgroups or different endpoints
Produce multiple graphs at once for different audiences
and documents
Listen to this episode and share this with your colleagues!
How to run effective meetings, even if you are just a participant
In this episode, I talk about the important questions that we need to answer and the points we need to consider to ensure an effective meeting. Here are the steps you can follow and what can you do if these steps are not followed in a meeting you’re invited to:
What is the goal you want to achieve?
Do you need a meeting at all?
Who is really needed for the meeting?
Who will contribute?
Who could derail the outcome?
Who would you need as an ally potentially?
How long do you need the meeting to be?
Additional tip - start 5 minutes after the hour and stop 5 minutes before the hour
Send the meeting agenda
Always include the goals of the meeting
Include any pre-reads
Any action items specifically for some of the attendees (do you need to prepare someone 1:1 beforehand)
Start on time and end on time
Start with the goal
Table any topics that derail from the goal
Ask also those that are quieter
Organize minutes from the start (maybe display them on the screen)
Who does what by when - clearly identify action items
Virtual meetings - turn on the video and set this expectation beforehand
Listen to this episode now and share this with your friends and colleagues!
Everything you need to know about matching adjusted indirect comparisons
In today's episode, Wei and I dive deep into the future of safety analyses and discuss the following topics:
For interactive tools - how can we achieve traceability of what we looked at demonstrating transparency on the decision process in an interactive tool?
What are your experiences in developing an interactive tool?
What are the best practices for data visualizations for safety?
How can we give external parties like the FDA access to such tools?
Listen to this episode and share this with your friends and colleagues!
How to play the game of business to build stronger, more innovative, more inspiring organizations
Click this link to go to the homepage of this episode!
In today's episode, Benjamin and I talk about different time management hacks to be productive and efficient while working at home. We also talk about these following important points:
Things you should first establish:
Be clear on your goals and keep them in front of you
Focus on building great habits as these will carry you to success
Three time management hacks:
Saying no and turning things back - reflect work
Focus your efforts and concentration (schedule time, manage distractions)
Get and stay organized (calendar, to-dos, meetings, filing ….) - apply the 4 principles from Atomic habits
If your answer is yes, I am sure that you'll be very interested to hear the story of Matthew and Emma as they will be sharing today their experience on how they started their own company, Veramed, in 2012 after having their established careers working in the industry for both large pharma and CROs.
We also talk about the following points:
What is the founding story of Veramed?
Why did you start it in early 2012 after being a freelancer for some time?
Leaving a nice and “secure” job at Lilly, how did that feel like and why did you leave?
How does the business model for Veramed look like?
How did you grow your company in terms of getting more business, recruiting new people while retaining the right people and also securing the right quality/culture?
How did you manage to balance family vs work being the owners of the company?
Listen to this episode to learn a lot and share this with your friends and colleagues!
In today's episode, we discuss how to manage problems with efficiency, clarity, logic, consistency, alignment, and speed. Also, the 8 steps to make a smart decision :
Today, we are talking about so-called win-win situations. Win-win is a situation that has the potential to be beneficial to all involved. Justine and I also discuss the following points:
Examples of career drivers
The roles of to help your progress?
Many larger pharma companies have technical tracks and management tracks. What skills help statisticians move forward on both these tracks?
What common problems hinder statisticians progressing in their careers and how to overcome or avoid these?
Listen to this episode now and learn more on how to create a win-win situation!
Today, I talk with these two awesome visualization experts - Eva and Andy. They have written great content about data analysis and visualization. Learn a lot about great visualizations from them. We discuss the following important points:
And today, we are looking back and discuss the last 2 year's learnings. We discuss the 9 learnings we had and how they apply to you as a listener as well. Specifically, we talk about:
Think bigger
Prepare for the unexpected
Delegate what you are not good at or what you don’t like
Have fun
Relationships are the foundation for success
Be curious and dig deeper
Our community is big
Unnecessary red tape differs a lot by company
Growth happens outside your comfort zone
We need to all step up to improve the impact of statisticians for the benefit of patients.
Listen to this episode, share it with others, and learn more!
Why and how to declutter and simplify your data visualization
In episode 3 of this mini-series, I discuss the impact of simplified data visualization and how to achieve it. Specifically, I address these factors that affect your visualization:
Clutter
Mis-alignment
Too many visual lines
Example misalinged header, legends,
Long categories below vertical bar charts not fitting well under the bars (avoid diagonal)
How many horizontal and vertical lines (start and stop of visual elements) do you have?
Can you avoid a legend?
Do you need these gridlines?
Do you need tickmarks?
Too many elements like
Colour
Fonts
Bold, italic
Annotations
Header, subheader, sub-subheader
“Unnecessary” annotations
File names
Source data
Program name
Validation status
Understand gestalt principles
Proximity - put the description for treatment next to the lines - not in a legend
Similarity - re-use color for the lines and the font color of the treatment
Enclosure- box around the most important area (e.g. randomized period vs open-label follow up)
Continuity - bars being organized below each other have a same starting point - take out the line showing baseline
Connection - connect what belongs together - line charts over time
Closure - take away the box around your overall vis
Learn more on how to create simple but effective data visualization by listening to this podcast and share this with others who might learn from it!
I discuss my learnings, my reflection about this, and what is the meaning of this situation for us, statisticians, and more significant factors like the following:
Hardly any tables out there, but lots of visualizations both interactive and explanatory - still most of our day-to-day jobs are providing tables
Get the data from many different sources - not just the one source at hand: e.g. the study currently working on; RWE, literature data, and other studies
Many misunderstandings on the sources of the data and comparisons across different sources (e.g. different countries) and then infer on the differences between the policy making in the different countries - where are the statisticians in the news explaining the numbers?
We need more leadership
Our associations need to step up and become more professional and impactful
We have a responsibility here
Responsibility for providing the numbers but also gives the background and advise on how to use the numbers - for example John Hopkins
FAQ not really helpful
What can be answered here and what not
How reliable is the data?
What are the strength and limitations?
Any guidance on the use of the data?
Do we train people on how to read our data? Or do we just through the tables over the fence for someone else to deal with it?
Power of scenario simulations - Washington Post article - great to show conditional probabilities e.g. if you have different prior information in Bayesian analyses
Listen to this timely episode and let me know what you think!
In today's episode, I review the different things you need to consider in creating an effective data visualization when presenting, which is the following:
Who is the audience?
Level of understanding
KOL
Researcher
Statisticians
What is the medium?
Presentation
Email
Paper
How much time do you have?
Who is the presenter? Is there one at all?
Understand how your visualization is used downstream
Despite her having a weak position in society at the time - being a nurse and a women – she still was very influential and achieved a lot. Many statisticians feel like they are not part of key decisions and don’t have the impact, they could have. What can we learn from her in this regard?
Imi works on such data on a daily basis and I’ve worked on observational studies since 2004. In this podcast episode, we will explain some of these topics, bust some myths and help you to understand how this data fits into the bigger picture.
Listen to this episode and share it with others who might learn from it!
Today's interview is surely beneficial to everybody. Andy Grieve has a lot of experiences across the industry as academia and other senior roles.
We also talk about the following points:
When did you realize for yourself, that statisticians should and can play a bigger role?
How would the health sector look like, if statisticians would have considerably more influence - e.g. if all the pharma companies would have something like a chief statistical officer?
What are the factors, that play in favor of statisticians gaining more influence?
What do you see as the biggest barriers for statisticians gaining more influence?
What would you recommend to other statisticians to achieve a bigger influence?
Do you have different recommendations for statisticians earlier or later in the career?
Listen to this interview and listen to others who can learn from it!
Overview of different indirect comparison approaches and methods
During this episode, we will review some of the highlights from this year. It’ll help you to remember a couple of lessons learned or inspire you to listen to some episodes (again).
We will talk about the following:
Leadership
The look beyond pharma
Data science
Benefit-Risk
Career
Nonparametric
Visualization
Productivity
And an outlook into 2020
Otherwise, enjoy your Christmas break and we’re taking a week off on New year's eve and start again on the seventh of January.
Listen to this episode and become an effective statistician! Merry Christmas!
CALC Episode 5: You’re hired! How to Fail to be Rejected During the Interview Process
I once reviewed tables for a randomized study and noticed several comments about testing the baseline characteristics. The commenters were arguing which test would be best to test for the differences between the 2 randomized groups at baseline.
This made my first angry about the wasted time and then curious about the reasons, statisticians still do this.
In today's episode, Benjamin and I discuss some backgrounds for baseline testing in randomized studies.
Listen to this episode, share it with others who might learn from it, and be an effective statistician!
Seeing through the mist - consequences of decisions in phase II
Do you often find your workday spiraling out of control? Do you want to be more productive than you yesterday? Do you want to know how to improve your skill set and work performance? Do you start each day with a plan, but soon become distracted and procrastinating?
You are not alone. Sometimes, it’s easier to wait for someone else to tell you what things you should work on rather than to assess yourself.
Focusing on continually improving your skill set will boost your confidence and help you become the best version of yourself.
In today's episode, Benjamin and I discuss what you need to know to increase productivity:
In this episode, I speak with Jennings Xu, who works as a Director in Quid - an AI natural language processing company. Here are the points you can learn from the interview:
What is zettabyte
What are the different modes of data
Where in the medical field is the biggest problem amongst text data
What are the other concepts used in text mining
What is the difference between text mining and natural language processing
Listen to this episode and share it with someone who might benefit from it as well!
CALC Episode 0: Introduction to PSI CALC Podcast Series
Storytelling is one of the great leadership skills that play a role in communication. Through stories, you can create alignment and you can influence others. It's one piece of a puzzle to be an effective statistician.
In this episode, Benjamin and I speak with Tricia Aanderud, a very good data storyteller. Here's what you can learn from the interview:
How to think about the story within the data
How to reveal your Aha moments
How to get into details while keeping the big picture
How to build tension and impact the visualization
Listen to this episode and share it with someone who might learn from it!
Statisticians stepping up - leadership success stories - Part 2
In this episode, I'm speaking with two members of The Effective Statistician Leadership program. One is coming from academia and one is from a pharmaceutical organization - they both have interesting and inspiring success stories.
These are the points we have talked about:
How they took action to improve on their leadership program
How to help others understand your story
How to refine things from other's reaction
What impact the improvements in your leadership skills can have on your lives
Statisticians stepping up - leadership success stories - Part 1
In this episode, Gary and I will be talking about these major reasons why statisticians fail to lead and to overcome them. Specifically, we'll address:
Mindset
Bias toward technical skills
Lack of leadership understanding
Lack of big picture thinking
How to address the issues
Specific actions to take
Listen to this episode and learn about the opportunities to overcome challenges in leadership!
According to Jon, the key is to differentiate between some venting, that we need from time to time, from systemically and constantly complaining.
Take this Power of Positive Leadership Self-Assessment and complete the questions to know your Positivity Quotient Score. By knowing your score you will be able to establish a baseline for growth. You'll also receive Jon Gordon's 6 Quick Tips to Help Stop Negativity in It's Tracks.
In this episode, Benjamin and I will discuss the following:
Ask for advice on how to work together
Make proposals of what the manager could do to help with the situation
Clarify roles and responsibilities
Be a role model to others
Focus on what you can do
Concentrate on changing yourself
Non-parametric analyses - much more than just the Wilcoxon test!
Frank has something in common with Benjamin and myself - we all studied statistics in Göttingen and learned and researched in non-parametric statistics. Afterwards, we went into different paths. Whereas Benjamin started at a CRO and I joined large pharma organizations, Frank continued on the academic track.
He recently became Professor at the famous Charitee in Berlin, where he’s still dedicating a lot of research to the field of non-parametric statistics. However, he’s not an ivory tower researcher but also applies these approaches in the medical research he’s taking part in.
Learn about a whole universe of different approaches, which will help you overcome many limitations of the methods, which you’re using daily.
This episode is based on a presentation at PSI 2019. Necdet won The Effective Statistician Best Presenter award for the amazing delivery of the presentation. But not only the delivery was excellent - the content will help you a lot. Here's the abstract for the conference:
Abstract: Practical aspects of subgroup detection Recent years have seen the emergence of new methods for detecting subgroups with enhanced treatment effects and statisticians are now faced with an overwhelming choice of approaches to consider. Confusion around the potential advantages and disadvantages of different methods can often result in the implementation of an approach which is not appropriate for a particular research question. This talk will provide a practical guide to the design and conduct of subgroup detection analyses, providing points to consider for selecting an appropriate method based on the research objective, the context of the analysis, the outcomes, and the covariates under consideration. Two example case studies will be presented to illustrate the discussed considerations.
Necdet and I will also discuss the following
Do you have practical examples based on a given data set that leads to very different approaches?
As a PSI awardee of best presentation in this year's conference, How do you approach presentations?
What’s your key recommendation for giving a great presentation?
It all started when I became a new supervisor and had my first direct reports and I thought I really needed to learn about supervisory skills but I have very limited time. I found out that podcasts really help a lot to learn while I commute to work - it's effective.
In this podcast, you can learn a lot from the following:
What are my learnings along the way?
What are my struggles?
What are the strategies I used?
How I balanced work and family life?
How the production team helped me?
What the effective statistician means to me?
What matters most? A scientific advice role play on estimands
Are you a sponsor who is seeking joint scientific advice from a regulatory agency and from an HTA body?
If yes, this episode is for you. This presentation replicates the discussions which may go on during scientific advice. The example was in Respiratory. This roleplay is played by David Wright, Oliver Keene, Stephen Ruberg, and myself. The aim is to show a couple of discussion points and an interesting aspect that may come up with such discussions.
A lively debate followed about the differing needs of Regulatory agencies vs HTA, with the patient voice often not taking centre stage.
We will also be talking about the following:
Estimand for pivotal trials 5062018 and 5062019 (identical trials)
Specifically strategy for intercurrent events
Listen to this episode and share it with others, who might learn from it!
You can lead as well. According to Forbes, best leaders lead with questions, not answers. Leading with questions works because really good questions have a direct impact on the brain. When we are challenged by a question that triggers an insight, neurons connect in new ways. This releases neurotransmitters that create the motivation to act. The net result is that the other person not only likes the idea, but they also want to do something with it.
In today's episode, Benjamin and I will be talking about:
How success looks like
How to create a win-win situation
How to get the team involved in creating the goal or at least tune into building relationships with people
How to move backwards once you have the goal, and put action steps into place to drive the project forward
How to drive things by one-on-one
Listen to this interview and share it with others, who might learn from it!
Help to make your organisation and yourself outsourcing proof
A lot of statisticians, especially in pharmaceutical companies but also CROs, fear outsourcing because it might make their job redundant. Think about:
In this episode, Benjamin and I will be talking about these tips and tricks:
Benjamin and I will be talking about these tips and tricks:
What are the things, that are done better, faster and cheaper by others?
Does your supervisor know about your value? Do you help him or her to understand this? – Listen to our episode on selling your achievements
Would your business partners care, if you would be replaced by a statistician at a different company or maybe even by a statistician within your organisation? Would they even notice? Might they even be better off?
How to communicate effectively by telling data stories
Storytelling allows businesses to better understand insight.
Data visualization is a great tool to help share, or tell a story, but relies on the story being written first. Improved data communication comes from combining good visualization with a well-written narrative.
At storytelling with data, the goal is to rid the world of ineffective graphs and help people elegantly communicate with data. They aim to bring data to life and use it to tell a story to an audience, with a focus on simplicity and ease of interpretation. They believe everyone can inspire positive change through the stories they tell with data.
There's a lot to learn to be a good data storyteller.
Today, I’m talking with Kat about:
What do you understand by storytelling with data?
Why is it important?
Which role should statisticians play?
What skills do statisticians need for this?
Where to learn these skills?
How to make the collaboration between sponsor and CRO successful
There is an endless list of things that can go wrong. I'm pretty sure you have been in painful discussions about this. Have you felt a lot of frustrations on both ends?
Benjamin works for the CRO and I work for the sponsor side. In this episode, we will be giving you a lot of insights on what to do and what not to do, and how to make collaboration between the sponsor and CRO successful.
Specifically, Benjamin and I will be talking about:
Have partnership on an equal level
Create common expectations on quality
Establish stable personal relationships
Have low turn over rates
Transparency of processes is important
Have a fair payment
Invest in creating trust
Good feedback habits
Work towards CRO processes and SOPs
Choose your vendor wisely - a good choice is half the success
In this series of interviews with the speakers at the conference, we talked about different topics:
Visualization software
Benefit risks approach
Global statistical test for multiple endpoint analysis
Estimands
AE analysis using a volcano plot
I also talked to Rachel Phillips at the PSI conference. She is an NIHR doctoral research fellow at Imperial College London. Please help her with her study. It will help all of us in the end and you can win something!
This is a survey of clinical trial statisticians with experience of planning and performing final data analyses for pharmacological RCTs to explore their awareness of available statistical methods to flag adverse events as potential adverse drug reactions (ADRs) and identify any potential barriers to their use, as well as gain feedback on ideas for new statistical methods.
They would like participants to provide their personal views. This study is being organised and sponsored by Imperial College London.
This study is funded by the National Institute for Health Research (NIHR).
The survey should take no longer than 10 minutes to complete and all participants will be entered into a prize draw to win a £50 Amazon voucher.
The survey should take no longer than 10 minutes to complete and all participants will be entered into a prize draw to win a £50 Amazon voucher.
Do you agree that everybody makes mistakes? Have you had to deal with a mistake yourself, that you were really concerned about? Were you afraid about speaking with your supervisor or your team with it?
We are all imperfect humans making mistakes. The questions are:
how do we deal with them,
what we can do about them, and
what to do to minimize them.
Processes are made to minimize mistakes and there different processes were set up to deal with mistakes and help you when mistakes occur.
Have you been sitting in boring presentations that made you start reading your emails? Have you been listening to someone, wondering if this is for me? Have you been getting away from a presentation and thinking 2 hours later: “what was this about?”
You’re surely don’t want your audience to feel this way, when you’re
presenting yourself. You can’t be an effective statisticians without good presentation
skills from my perspective. You will always need to present results, defend designs,
or explain data.
Todays episode will give you insights into 7 mistakes of presentations.
And honestly, I see at least one of them in nearly every presentation and I
struggle with them as well – just listen to this episode and you’ll have a live
example 😊.
The last PSI conference has just ended, but the timeline for a new abstract submission for the next one in Barcelone in 2020 will come up in about November 2019. Thus, it’s important to now start thinking about it.
Presenting at the PSI conference is an awesome experience. For me, PSI is by far the best conference for statisticians in the health sector as it is 100% applicable and actionable. If you’re abstract gets accepted for oral presentation or as a poster, you have a great argument for convincing your supervisor to approve the travel to Barcelona.
If you think, this is to much of a stretch, because you’re not located in Europe, just think about a different conference.
Join the challenge to submit an abstract and work together with others to overcome and roadblocks!
Are you up for a job change? Insights from a recruiter
Have you ever considered to work with a placement student?
Do you consider to spend some time as a placement student yourself?
In this interview with Katie Thorn and Claire Brittain, we’re exploring factors, which help to make it a win for both sides. Both have worked very well together and share their stories.
Questions to ask yourself before starting a new project
I recently talked to a statistician, that initiated a small company internal group of statisticians to drive forward methodological innovation projects. While this surely will help the individuals to learn more about statistical methods, it was less clear, why and on which topics the group should focus their activities on.
While most of our day-to-day activities consists of running clinical studies, submissions and directly related work, we also engage in such innovation work streams or process improvement working groups and other such activities.
Today, we’re giving you advice on how to best pick the right projects to work on as you usually have some influence on this.
Understanding heterogeneity for patient preference data and how it effects the benefit-risk ratio for treatments
As
statisticians in the medical field, we’re used to study subgroups of patients
with respect to all kinds of biological variables: from demographics to
genomics. This provides us with a good understanding of how the benefit-risk
profile for a given patient looks like.
However,
the patient might have a completely different view on the importance of the
different benefits and risks. And importantly, these preferences might be less
driven by biologic factors and more by personal experiences and situations as
well as psychological traits. How can we assess patient preferences in this
regard?
Marco
Boeri and I worked on such questions in the past and some work has been presented
at last years PSI conference. In todays episode, we give you some insights into
what’s possible and how you can approach this problem.
Useful tips to apply the composite estimand approach
Estimands continue to be a hot
topic, but many statisticians struggle to put it into practice. As
statistician, we wonder about the correct interpretation and how to analyse
different estimands.
In todays episode, we speak with Michael
O’Kelly, an expert on this topic with lots of presentations around estimand
(see e.g. the PSI events). He also won the award for Statistical Excellence in
the Pharmaceutical Industry, jointly run by the RSS and Statisticians in the
Pharmaceutical Industry (PSI).
Advanced approach for subgroup analyses in easy steps - SIDES
One of the most common questions I got asked during my nearly 2 decades of being a statistician sounds similar to this: “Which patients have the best response to treatment?”
I’m sure, we all face this situation sooner or later and not surprisingly lots of research has happened in the last years on this area. In todays episode, we will help you to understand one of the best approaches I have come across to solve this problem in a rigorous yet sophisticated way: the SIDES approach.
Both Andy Nicholls and I have applied this approach in the past and we’ll use an example, which he presented during a PSI webinar.
Listen to this episode to learn step by step how to apply the SIDES method.
Prespecified=good and post-hoc=bad. This is how we as statistician see it usually and I did too. However, over the past years I realized more and more, that it’s not that easy.
How many details do you need to have to call an analysis pre-specified? Should we label a request to analyse a certain subgroup by regulators as well as a fishing expedition to find a significant subgroup both in the same way: post-hoc?
Lovisa and I together with some others are presenting at the next PSI conference about this topic and today, we dive already into this topic and identify different dimension to be considered to understand better the different shades pre-specified analyses.
Listen to this episode to avoid oversimplification and confusion in discussions in the future.
Analysing binary or
continuous data usually doesn’t cause any headaches for statisticians. But when
we step into ordinal data, most of us ignore their specific nature and either
dichotomize them or analyse them as if they are continuous.
Recently, these
problems have becoming much more prevalent due to the nature of composite
endpoints (watch out for an interesting episode on this in a few weeks).
Now Benjamin and I
have worked on better tools to analyse such data already at university. We’ll
dig back into what we learned then and what is still relevant today.
Risk-based
monitoring plays an increasingly important role for clinical trials. Of course,
the assessment of the risk is based on statistics. This presents now only
interesting career options for statisticians, but also has an impact on the
role of statisticians in study teams.
In this episode, we’ll give you an introduction to risk-based monitoring (RBM) as well as speak about the role of statisticians in this area. Further we provide you as a study statistician insights into what you need to know about RBM. Finally, we also give some recommendations in terms of further resources to learn from.
How to train non-statisticians effectively - 11 tips to succeed
Ultimately, we work to improve patients lives but
traditionally the voice of the patient was not important. However, over the
last decades many stakeholders shift to include the patient more in the decision-making
process and patients voice their needs and preferences more.
Still capturing and evaluating patient preferences does not belong to the core capabilities of most biostatisticians. This episode will help you to understand patient preferences.
Benefit-risk assessments are made by various stakeholders including sponsors, regulators, payers, physicians, and patients throughout the life-cycle of a treatment.
The understanding of data plays a vital role in weighting positive and negative effects of medications.
In this episode, we give you an introduction to what benefit-risk (BR) assessment is in order for you to understand your role.
This episode follows the outline of a webinar, that I presented in 2018 during a PSI webinar. I’m introducing cluster analysis and why you as a statistician need to know about it.
Data science or just statistics on non-medical data? A new horizon for statisticians
There’s a long tradition of statisticians working on clinical studies as well as other related data, e.g. pre-clinical data and observational data. In the advent of big data and data sciences, there’s a considerable pull from the business side of pharma to employ statistical approaches as well.
What does this mean for medical statisticians?
Current trends in data science for pharma – findings from a qualitative survey and what we should do about it!
It's surely not the norm, that a statistician from the pharma sector ends up working for BBC. But Robert Cuffe has taken this step and needs to explain statistics to non-statisticians on a daily basis.
In this episode, he shares the different methods he’s using. We also dive into common pitfalls, that we as statisticians trap into.
Finally, we also learn, how we can improve our publications to make sure, that the science is reported correctly in the broader news
What is TransCelerate and how it will impact your work tremendously
Do you think, R can’t be used for regulatory submissions?
Are you forced to use SAS but would like to use R instead?
Would you like to understand how you can make R submission proof?
Then this interview with Lyn Tailor and Craig McIlloney helps you.
Both work on the PSI special interest group Application and Implementation of Methodologies in Statistics (AIMS) on this topics.
In this second part of the interview with Gary (check here for part 1), we speak about the building blocks of leadership without authority from a statistician’s perspective. We cover questions like:
Is influence the same as power?
What is the role of trust, what are the different elements of trust and how can we improve trust being technical experts?
How can we build relationships at work, that help us to influence change?
Is influence through relationships only relevant “sideways” or also “upwards” and “downwards”?
How do we know, with whom we need to invest in building relationships?
Is there a way of assessing how good our relationships are?
Free webinar: 4 reasons why statisticians fail to lead and how to overcome them!
This is an announcement episode of an upcoming free webinar. Learn more about this webinar and register for it at theeffectivestatistician.com/webinar.
Impress your supervisor by being super prepared for your goal setting discussion
With some nice drinks in our hands, we welcome the new year and commit to new year resolutions. We set our personal goals and pretty soon, we’ll have discussions at work about business related goals.
This episode will help you to not only be ready for the discussions with your supervisor, but also give you tools to reach the goals with better probability than the usual vague new years resolutions.
Best of the episodes from 2018 and outlook for 2019
Happy Christmas! This episode is the last one in 2018 and we will distil the best of the last 40 episodes for you in this Christmas edition of the podcast.
It has been anamazing journey and we will talk about the challenges and the learnings as well as the achievements of the podcast itself. Thus, you’ll get a behind the scenes look into the podcasting work.
KOLs play a major role in the health sector and professionally working together with them will boost your career! This episode provides you with lots of insights and tips.
In this episode, we talk
about how the interactions between pharma companies and KOLs look like
which rules are important and how you as a statistician should comply with these
about practical tips of building relationships with KOLs
If you ask someone within the pharma world of statisticians on what is the hottest topic, you most likely will just get: Estimands!
Many scientific events, conference sessions, publications and presentations are organized around this topic. Thus, I'm super happy, that we have Mouna and Chrissie on the podcast as they have presented about this topic at various occasions.
In this episode, you will learn about
the importance of the concept itself and it’s implications
Have you ever been proposing or defending a project in a larger meeting - maybe even with senior management - and it didn't go as smoothly as you would like?
Or do you prepare yourself for such a meeting and you feel unsure about what to expect?
Then this episode will help you!
How to prepare for your year end review to stand out!
Same procedure every year - the year end review as part of the performance management appears on your calendar. Are you worried about filling in forms? Do you feel like this is not adding value?
In this episode, we give you practical tips how to master the review like a pro.
Why should statisticians care about leadership and developing their leadership skills?
Today, regulatory approval doesn't ensure anymore, that patients benefit from new therapies. As statisticians, we also need to ensure access and reimbursement for new treatments in the different markets around the world.
The process to gain this access and reimbursement in Germany comes with very specific challenges. Yet, due to the large impact of Germany on other countries via the complex reference pricing system and the size of the population of Germany, we must understand these topics.
Andreas Schwenke gathered experiences across therapeutic areas with many companies since the start of the new process in Germany. This makes him the most experienced and best connected statistician in the world for this topic.
By listening to this interview, you will
get an understanding of the importance of the HTA process in Germany,
learn about key processes and stakeholders to reach successful reimbursement,
We're all making decisions to optimize our studies. Optimizing project plans across different studies presents further challenges. But how to increase the overall portfolio of a company given its limitations leads yet another set of challenges. Knowing how decisions are taken at this top level helps to understand the bigger picture and why this sometimes implies sub-optimal decisions on a study or compound level.
Another big learning from these complex interactions are the influencing skills needed to work with senior and diverse teams.
Only a few statisticians in the industry work in these areas and Andreas Sashegyi is of these.
British Airways, CROs, Programmers – why you should start with Why
You have probably heard about Simon Sinek and his golden circle. If not, have a look at his great TED talk.
In this episode we explain via a nice story with BA, what the impact of starting with why can be. We also cover how you can more effectively work together with CROs and Programmers as well as new team members.
Being a supervisor – things you would love to have known before you became one … or that you should know if you want to
Becoming a supervisor changes things dramatically at work for you. It did for me and Simon helped me by openly providing deep insights into his years of a supervisor - especially his failures and dramtic moments.
In this episode, Simon shares his ups and downs for you to learn from. Leading statisticians of course have many commonalties with any other administrative leadership position. However, it also includes some specific problems.
Everybody knows such situations: tight timelines, high expectations and many things to do!
But how can we work effectively in such situations. Many different productivity experts have written about this topic.
In this episode, I’m speaking about how to implement these approaches and also my personal learnings and challenges during a time, where I needed them.
Leadership skills for statisticians represents a common theme across many episodes of this podcast. As leadership consists of many different aspects, it is important to learn from other statisticians, that exhibit these skills.
In this episode, we talk with Gemma and Margaret, who have run successful leadership courses within PSI. We cover the following topics:
What are the core leadership skills that statistician need to be fluent in?
What are common mindset issues, that block statisticians from being more influential?
How can statisticians overcome these blocks?
Why it’s beneficial for statisticians to have a tailored course for them?
Do you think, you have nothing to add to a statistical conference? Are you afraid of sharing your achievements? Do you wonder, why you should put in the effort on top of your day-to-day job?
All these thoughts and questions will be addressed in this episode with Paul Terrill, the chair of the scientific committee of PSI.
Beyond the questions above, we will also talk about the logistics and practical tips on how to submit your abstract and to become a speaker at next years conference.
Have you ever felt bad about talking about your achievements? Did you ever thought, that you're just doing your job, when you accomplished something? Did you ever feel, that others didn't understand, how significant your contribution was?
If your answer to any of these questions is yes, this episode is for you!
Multiplicity - practical tips with Alex Dmitrienko
Understand and master multiplicity in practical situations - Interview with Alex Dmitrienko
Alex Dmitrienko has researched and published so much, that without a doubt, he can be called one of the world class experts in the field of multiplicity. E.g. his book Multiple Testing Problems in Pharmaceutical Statistics contains a wealth of practical information on this topic.
His career has brought him from pharma over CROs to his own company Mediana. Via his company, he provides also online courses on his favourite topic.
As a listener, you will get the following benefits from this episode:
Understand multiplicity challenges in practical situations
Learn how to actually implement it
Learn where to get further information
We cover the following topics during the interview:
What is multiplicity and why does it matter?
Should we always test as many objectives as possible or is it better to restrict the list of objectives?
How do we communicate best those objectives, that are non-significant on the multiple testing adjusted case but are significant on the local level?
Non-regulatory stakeholders like payers and physicians may have completely different views on the priority or importance of variables. How should we manage this?
There are many different ways how setting up systems for multiplicity adjustments. What are the best steps to come to an agreement with a cross-functional team on this?
How do we deal with multiplicity, if the study has different components?
How do we deal with multiplicity, if we have 2 or more studies and analyse them combined as well as individually?
What are good resources to learn about multiplicity for beginners?
20 key attributes of highly successful leaders part 2
In this episode, I have the privilege to interview Walt Offen. A statistician that is about to end an amazing career over a couple of decades of working in the pharmaceutical industry.
Walt organized together, what he believes to be the 20 key attributes of highly successful leaders. They are organized in no particular order but enriched with great stories.
Of course, there is a difference between leadership and managing. Leadership is the ability to inspire others when there is no supervisory control. For a highly effective organization, everyone can and should be a leader. In part one, we cover the first 10:
Having a can-do attitude
Being able to apologize
Inspiring others to join the cause (without authority)
Share credit
Show humility
Be trustworthy and develop trust in others
Engaging everyone on the team, making them feel valued and important
Remain calm, be kind to everyone
Provide opportunities for others to shine
Putting the organization, colleagues, the company, ahead of personal goals
About Walter W. Offen, PhD
Distinguished Research Fellow
Global Head of Statistical Sciences
AbbVie
Walt is currently Distinguished Research Fellow. He heads up an organization comprised of Statistical Innovation, Safety Statistics, and Non-Clinical Statistics. He received his PhD in statistics from the University of Florida in 1980. His career began at Eli Lilly, spanning 31 years. He joined AbbVie in 2012. His interests include novel clinical trial design and analysis, Data Monitoring Committees, and multiplicity. Walt was inducted as a Fellow of the American Statistical Association in 2007.
Indirect comparisons provide evidence, when no direct clinical trials are available. However, the different approaches come with various limitations. Some more recent approaches take into account the baseline characteristics to reduce the bias in the estimates of the treatment effects.
In todays episode, I'm talking with one the worlds experts on this topic - Nicky Welton - who has published extensively in this field.
Starting from the basics of indirect comparisons we move into the most recent research in this area. These new approaches will help to better understand treatment effects in specific populations of interest. Possible applications run from designing phase II or III studies up to re-imbursement dossiers and commercialization efforts.
Estimands in the presence of high and unbalanced drop out rates - a case study in the German HTA system
As a statistician we delegate all the time with programming being probably the most prevalent example.
In this episode, we start by showing in two personal examples how delegation improves your productivity amazingly or how it can lead into complete disaster.
Furthermore we cover the following questions:
Why is delegation so important?
Why are not only managers delegating?
Why should I delegate, if I can do it myself?
What task can I delegate?
How can I delegate appropriately?
Why are many people not delegating more actions?
By listening to this episode, you will also learn about these 4 principles of delegation:
Any task should be done by the most junior team member possible.
Delegate tasks in such a way, that they are interesting for the people to work on.
Specify what goal you want achieved, defining together what a great outcome looks like and support as needed, but resist the urge to tell exactly how to achieve the goal.
Delegate deliverables not tasks
The episodes concludes with a discussion on the how to create an environment where
your team members thrive,
you successfully reach great project outcomes,
people are motivated and engaged, and
both team members and leadership wins.
Impactful influencing: actionable advice to get things done through and with others
In this episode we have our first non-statistician as a guest. Julia has build her own consulting and training company Zestfor. She and her team specialise in developing Training programmes and resources scientifically tailored for technical markets – including Pharmaceutical, IT, and Life Sciences.
Getting things done through others is a key part or even the definition of leadership and her clients face often the same situation like statisticians. They need to convince people rather than commanding them.
In this episode, we cover the following topics:
Why statisticians need to be more influential?
Is influencing actually something bad on inappropriate?
What characterises an influential person?
Which practices help statisticians to increase their influence?
Many statisticians are more introvert. As such, how can they deal with more extrovert business partners from other functions?
Relationships are key for influencing without authority. Trust is key for building these relationships. What can statisticians do, to generate more trust?
Networking is another aspect of building relationships. What actions to take to build networks?
Many of us work in virtual settings to some extent. This poses additional barriers on influencing others as it is much harder to be heard and understood. Which techniques can we apply to overcome these hurdles?
How to successfully submit a reimbursement dossier in Australia?
In order to make new drugs available to patients in Australia, a successful interaction with the PBAC – the Australian HTA body is needed. Alan Brnabic lives in Australia and collected a lot of experience with these submissions over the years.
In this episode, we cover:
the basics of understanding how the PBAC works,
why a successful PBAC submission is important,
what evidence is needed to have a successful PBAC submission,
how much work is needed from the statistician’s side for the PBAC interactions,
what are the typical challenges from the PBAC,
when is a good start to get prepared for the PBAC work, and
how is the data submitted to PBAC publicly available
As a statistician – do you take the back seat or do you drive yourself?
Ok – not everything, but in this episode you will get all the tips to make sure, you avoid the most common mistakes and that your code looks professional.
Shafi Chowdhury is an expert programmer who has developed a style guide, which his clients apply broadly. He regularly gives trainings on SAS programming and build his own company based on these skills.
He walks us through the different points and clarifies, why they are important from an efficiency but also from a quality perspective.
About Shafi Chowdhury
I have over 20 years of experience as a statistical programmer in the Pharma industry. I worked for Pharma companies and CROs across Europe in many different therapeutic areas and in all phases of clinical trials before setting up my own consultancy firm. I believe knowledge should be shared and therefore I am a regular presenter at PhUSE conferences and regularly attend many other conferences including PSI conferences for Statisticians in the Pharmaceutical Industry. I also provide bespoke training and have a website to allow users to learn just the module they need at that time.I specialise in reviewing processes and developing standards, tools, templates and macros to improve the expertise of individuals and efficiency of processes. As an independent consultant with all the proven experience behind me, I offer unbiased expert opinions which can be used by management to make their decisions. My aim is always to drive up Quality by Design.Specialties: Writing SAS programs to check, modify, analyse and report any kind of data. Developing client specific template programs and generic macros.Developing bespoke training programs to produce well rounded programmers within weeks.
In this episode, we’ll cover an amazing story by one of the best programmers and mentors I ever worked with - Shafi Chowdhury (www.shaficonsultancy.com).
We’ll explore how it changed from being a freelance programmer only to building his company on the side. He had a great vision in mind, that drove him forward.
You’ll also hear about his approach to teaching and mentoring – or in general helping people do their job better. His abundance mindset inspires me a lot. Shafi explains, why and how he made his own job redundant in his own company.
Retention is a major cost driver and disrupts some companies a lot. You’ll learn how he manages to have nearly no turn-over in his company and how is approach to recruiting and training new employees fits in to this.
Further, we’ll cover how and why Shafi and his team is regularly presenting at different conferences. We’ll especially go deeper on this presentation at the PSI conference in 2017 about an amazing tool to analyse and visualize data at the same time. His approach to delivering all this innovation is very unique.
Finally, you’ll learn a lot about the leadership attitude, that helped him grow his business fast into a medium sized CRO with a very stable client base.
In this podcast episode, we tackle a difficult topic for a podcast, but Zak provides lots of expertise in this field and will introduce you to what visual analytics is and how it will help you.
Furthermore, we touch on questions like:
What is the difference that visual analytics plays in 'exploring/learning' and 'messaging'?
Why is visual analytics important? Why should I care?
How does the job of a statistician in visual analytics look like?
Is visual analytics purely descriptive and exploratory in nature?
What does the future of visual analytics in the pharma industry will bring?
How can you implement these approaches in your day to day work?
What tools are there for beginners, people with decent programming or advanced programming skills?
What you can expect from Zaks presentation at this years PSI conference in the wednesday morning session “A picture says more than 1000 tables- interactive data review using visual analytics”
About Zachary Skrivanek
Dr. Skrivanek graduated with a Ph.D. in biostatistics from Ohio State University and a B.S. in Industrial and Labor Relations from Cornell University. Dr. Skrivanek’s research interests started in genetic linkage analysis. He has published several papers and presented at Joint Statistical Meetings in this area. He developed a software package, Sequential Imputation for Multi Point Linkage Estimation (SIMPLE), to implement the methods that he developed.
He joined Eli Lilly in 2002 where he contributed to the development of Endocrine drugs and related biomarkers in early clinical phase drug development and later transitioned to a product team in late phase clinical development as the lead statistician and developed a novel Bayesian adaptive, seamless phase 2/3 study which selected the doses algorithmically for the entire Phase 3 program for the compound. Dr. Skrivanek heavily leveraged Visual Analytics in his compound work and is currently leading an effort to make Visual Analytics an integral part of drug development at Eli Lilly.
Dr. Skrivanek is also an adjunct professor at IUPUI (Indiana University Purdue University Indianapolis) and chair of a lecture series, “Pharmaceutical Statistics”, which is taught as part of the doctoral program in biostatistics at IUPUI.
How to become a world expert in an indication as a statistician
If we think of world experts, we often think of people, that are candidates for the Nobel prize. We tend to have the believe, that we will never be able to achieve such a status. Actually most of us probably don’t even think about getting to this level.
This is why we are so happy to have Claire Brittain as our guest on the show. In an ordinary role of a statistician working in early phase, she has done outstanding work.
Listen to her story of how she came to be called a world expert on Progressive Supranuclear Palsy (PSP), a rare neurodegenerative disease.
This amazing story has lots of learnings for each of us.
Finally, Claire will present a poster about her work at the PSI conference in Amsterdam. Actually, it’s not just a poster, but listen to the episode and you’ll learn what’s so special there.
In todays episode, we take a look into the future - the future of PSI and how it will impact you. Both candidates, that run for becoming chair of PSI - Lucy Rowell and Naomi Givens - speak about their vision in our interview today.
Of course, this episode will help you to decide who to vote for, but it will also help you to understand how to benefit from PSI by becoming an active member. Both candidates share their stories of how they got more and more involved within PSI and how they were able to impact the world of statistics through PSI.
In more detail, we’ll cover the following topics in the episode:
Experience of the candidates with PSI
Achievement at PSI and their current role on the board of directors for PSI
Why do they want to become chair of PSI
Changes to PSI, that the candidates would like to initiate
The candidates visions for the future for PSI and how to get there
How to write impactful and effective emails while avoiding common mistakes
Everybody uses email multiple times during the day and email represents a key communication channel. Managing the flood of emails effectively, will reduce your stress.
In this episode, we discuss various approaches, that we learned over the years from different productivity experts. We discuss how we implement them in our daily routines.
By listening to this episode, you’ll learn about these topics:
Data science, big data, business analytics … these are all buzz words in the industry at the moment and the hopes are high on what these areas will provide to our industry.
Cytel organized a long session about data science for the PSI conference 2018 in Amsterdam (learn more and register here).
In this episode, we’ll speak about:
Why is data science such a hot topic at the moment?
How can we separate the different buzz words?
Is this only something for google, amazon and such companies?
What distinguishes a statistician from a data scientist?
What are the biggest areas of impact for data science?
What case studies are there, where data science had a profound impact?
Which problems you might face?
Which role do visualization approaches play in data science?
What’s the difference between “machine learning” and “deep learning”?
What would a statistician need to know, in order to compete in this field?
Where are good resources for this (see also the Cytel blog here)?
Finally, we will dive into the sessions, which Cytel chairs as the main sponsor of the PSI conference. You’ll learn if this session is a good fit for you.
About Yannis Jemiai
Yannis Jemiai has a pivotal role within Cytel, leading the company’s consulting and software business units, as well as the global marketing group. With Cytel Consulting he heads up an elite team of biostatisticians, skilled in applying the latest trial techniques and methods, to help our customers accelerate clinical development and mitigate portfolio risks.
Yannis also oversees the development of Cytel’s software product lines, including trial design packages East® and Compass®, and exact statistics applications StatXact® and LogXact®. Yannis guides global marketing efforts to raise the awareness of and uncover new opportunities for the company's growing range of clinical research services and specialized software.
His own research has been published in numerous statistical journals. Dr. Jemiai earned his Ph.D. from Harvard University, an M.P.H. from Columbia University, and a B.A. in Molecular and Cellular Biology also from Harvard
About Rajat Mukherjee
Rajat Mukherjee has 15 years of professional experience as an industry and academic statistician, and brings a range of expert knowledge to Cytel’s customers. This includes work in pattern recognition problems for devices and biomarker discovery, Bayesian clinical trials, adaptive designs, and design and analysis of complex epidemiological studies. His experience and expertise also includes statistical computing, survival analysis, longitudinal analysis, nonparametric and semiparametric inference, as well as statistical classification and high-dimensional data. Rajat has a strong background and interest in the development and implementation of statistical methodology with application to real life medical problems.
Why should I get involved with PSI and what it’s like to run the PSI conference?
In this episode, we’ll cover Lucys story about her work within PSI and how it helped her to with her promotion. She shares tips and tricks to make it happen and we explore, what it takes to become an active PSI member.
Lucy is the conference chair for the PSI conference 2018 in Amsterdam. As such, we also talk about various hurdles and benefits of running such a large event. Lucy explains what you can expect from this years conference and how learnings from previous conferences are implemented.
Learn more about the details of the program etc and register for the PSI conference 2018 in Amsterdam here.
About Lucy Rowell
Lucy has been an active member of the PSI Scientific Committee for 6 years and this is her final year as the conference chair! Lucy is currently embarking on a 50% rotation into the UK Affiliate, supporting early pipeline molecules, from either a Medical or Marketing perspective.
During her 15 years at Roche, Lucy has enjoyed a 6 month secondment to the US and worked in a number of disease areas including: inflammation, virology, metabolism, infectious diseases and oncology projects, across all phases of clinical development and has been involved in designing a wide variety of trial designs implementing both frequentist and Bayesian approaches.
When not in work, you will most likely find Lucy out listening to live music, walking her dog Buddy or curled up on the sofa reading a good book with a glass of vino.
10 reasons for your supervisor to approve your attendance at the PSI conference
Are you afraid of asking your supervisor for approval to travel to Amsterdam to attend the PSI conference?
Do you need convincing arguments for them to approve your travel?
In this episode, we talk about arguments, that help you in your discussion with your supervisor. We're talking specifically about the PSI conference 2018 in Amsterdam, but these points will very much be applicable for future PSI conferences as well.
You probably don’t want to tell them, that Amsterdam is a very nice city and the social activities will be lots of fun. But here are some arguments, that might help you to get the approval:
The conference is highly relevant to statisticians in the pharma industry. There are no ivory tower research sessions with little practical applications. All the topics were selected having statisticians in the pharma industry as the target audience in mind. 3 days packed with specialized content.
Many of the sessions will help you to work more effectively in your job with higher quality outcomes. You will learn how other companies solve the same problems that you have.
The vast majority of speakers are very experienced presenters, that will enable you to learn much more in shorter time. Lots of work is put especially into the many invited sessions, to compose the different presentations and give you a holistic experience of a session rather than a collection of vaguely related topics.
There are a number of workshops during which you can learn hands-on skills to apply directly to your work. E.g. you can participate in a development and coaching session targeted especially for statisticians (not a general one, that any training company offers).
During the informal breaks and at the social events in the evening you may meet with your clients (if you work for a CRO) or your vendors (if you work for pharma) and build relationship and trust. This will make current or future collaborations much easier. Alternatively, it may help to build future business relationships.
Are you working on regulatory or HTA submissions? Many sessions and workshops will cover hot topics and after attending them, you will be better prepared for your high-impact contributions to these critical submissions for your business. You will also meet some staff from the HTA and regulatory bodies at the conference.
Do your business partners don’t understand what estimands are? Do they have a hard time to understand the Bayesian concepts that you’re applying? Learn at the conference to better communicate about these topics from industry leads on these fields. This will help you to be more impactful during critical conversations with your business partners and you can provide examples of how others in the industry are solving problems.
#8 Do you have a formal development plan? Put it in there and your supervisors will be happy that there is already something ticked for their HR deliverables. And if this is in-line with your business objectives – even better.
The conference is cheap compared to a DIA meeting or any international medical conference. Take further advantage of the early bird discount rate up to the 21st March 2018.
You have a poster to be presented at the conference. Ok – this only works, if your supervisors approved the submission of the poster. But it is always something for them to sell upwards, that you’re an active contributor. The poster deadline is the 28th Feb 2018.
Not every reason will work in every situation and with every supervisor. Try to understand, what goals your supervisor has and tailor these arguments towards these goals.
Register and find out more about the conference here!
Do you have more reasons to attend? Please leave a comment below.
How to collaborate with a programmer to create a smooth work flow
Lots of valuable tips on this very important relationship
In this episode, we discuss our experiences in working with various programmers and what we as statisticians can do, to create an environment, where we can work without major disruptions and too many stressful moments. We’ll cover topics such as:
In this episode, we speak about one of the most important work relationships – the one with the physician. As a statistician we work with them in all kind of things on the job. They also might become great friends.
In the episode, we will cover the following topics:
Topics to increase the understanding where the physician is coming from such as
How was he successful in his previous job – e.g. emergency room setting with command and follow setting to solve urgent crisis
Hospitals and physician’s offices are built with the physician at the center as he is the bottle neck
Has he even been a KOL before joining the company – that’ll make it hard for him to switch to a new culture
Mindset and tactics to create a successful partnership such as
Have 1:1s in which they you can answer their perceived “stupid” questions
be a partner and not a service provider
Present data together with the physician and show him, how you both can benefit
How to become a more valuable partner to the physician by e.g.
Provide draft conclusions based on analyses
Learn his language as you encourage him to learn yours
Have a physician as a mentor to learn how to best work with them
Tips on how to give the physician insights into your job and that it is not a push the button exercise
Welcome to “The Effective Statistician”. The podcast for statisticians who want to have a bigger impact. This podcast is sponsored by PSI.
Alexander Schacht and Benjamin Piske co-host this podcast.
In our episode 0 we will speak today about the content of this podcast. We discuss
who we are,
who is our target audience,
hat we will cover, i.e. what you will get from this podcast,
and how the format will be.
Who are we?
Alexander:
academic and industry experience (within the sponsor)
phase III and IV (RCT, observational studies, regulatory submissions, HTA submission, commercialization work)
different medical areas
interest in many different areas methodologically
group leader
changing environment from office based to working virtually
working from Germany
PSI involvement (benefit-risk special interest group, scientific committee member, getting more involved in communications)
husband and father of 3 kids
love running and listening to podcasts
I will mainly drive this podcast and will chat with Benjamin around various topics for the first season of this podcast
Benjamin:
- 14 years of industry experience (within CRO)
- originally started in phase IIIb/IV (interventional and NIS, commercialization work, publication /presentation support, investigator driven trials)
- by now also experiences in phase II and III
- variety of therapeutic areas (mainly oncology, hematology and neurology)
- manager for 9 years now
- working primarily office based in Berlin, Germany
- husband and father of 4 kids
Who is this podcast intended to help?
Statisticians
Experienced and junior
With and without administrative leadership positions
Mainly in the health sector
Statisticians / data scientists outside will benefit surely as well
What will be the topics of the podcast:
Goal is to become more effective at work
Build competency in terms of doing better statistics
Ongoing methodological discussions
Becoming a leader without a title
Influence without authority
Build your brand
Get the right things done effectively
Collaborate effectively within and across companies/organizations
Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). He co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.
Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). He co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.
