A Webinar Recording: Redefining the Role of Statisticians in a World of Real-World Data and AI
In this special episode, I’m sharing the recording of a webinar I co-hosted with Cytel on March 20, 2025. I was joined by an expert panel of leaders in statistics and clinical development: Yannis Jemiai, Flaminia Chiesa, and Benjamin Piske. Together, we explored how the role of statisticians is rapidly evolving in response to industry changes, data innovations, and AI-driven transformation.
This rich discussion dives into what it means to lead as a Clinical Data Scientist today—and why statisticians are uniquely positioned to influence strategy, innovation, and decision-making across the healthcare and pharmaceutical sectors.
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51:48
RWE and JCA - how do they go together
In this episode, I’m excited to welcome back Katrin Kupas, a statistician with deep expertise in Health Technology Assessment (HTA) and real world evidence (RWE). We dive into how RWE and the new Joint Clinical Assessment (JCA) process in Europe can work together—and where the challenges lie.
As the JCA becomes more central in EU regulatory and reimbursement discussions, knowing how and when to use real world data is critical. Katrin shares practical use cases, methodological guidance, and strategic insights for integrating RWE into early planning.
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20:21
Why and how you can promote more students become statisticians
As someone who found my way into statistics late—only halfway through university—I often wonder: what if more young people knew about this path earlier?
In this episode, I sit down with two wonderful guests and PSI volunteers, Emma Crawford and Alex Spiers, to explore exactly that: how we, as statisticians and scientists, can inspire the next generation.
We talk about the why behind investing in STEM outreach, share personal stories, and get into the practical steps you can take—whether you want to volunteer at a school, present virtually, or simply start a conversation with a student.
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29:32
Clarifying confusions around interim, primary, final, and other analyses in clinical trial
Group sequential trials, interim analyses, final analyses, updated analyses… what do these terms actually mean, and why is there so much confusion?
In this technical yet highly practical episode, I speak with Kaspar Rufibach, Principal Biostatistician at Roche, to unpack some of the most commonly misunderstood terminology and concepts in clinical trial design and analysis.
If you've ever questioned what really qualifies as an "interim analysis" or struggled to explain why a “final analysis” isn’t always the last word, this conversation is for you.
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31:11
Reimagining Clinical Trials with Synthetic Data and Digital Twins
In this episode, I had the pleasure of speaking with Prof. Holger Fröhlich, who leads the AI and Data Science Group at the Fraunhofer Institute and is an honorary professor at the University of Bonn. We explored one of the hottest topics in healthcare data science right now: synthetic data.
Holger and I discussed how synthetic data is generated using AI, what role digital twins could play in the future of clinical trials, and how these innovations could fundamentally reshape how we design and conduct research. We dove into the Cynthia Project, which is part of the Innovative Health Initiative (IHI) – the largest public-private partnership for health research in Europe.
About The Effective Statistician - in association with PSI
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.