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PODCAST

The Effective Statistician - in association with PSI

Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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

science natural sciences

All Episodes

24:20

How to communicate results from adaptive studies...

The Effective Statistician - in association with PSI ·

2025/10/27

Adaptive designs let us learn earlier, stop smarter, and protect patients—but they also make communication tricky. In this episode, Kaspar Rufibach and I dig into what “still correct” looks like when you try to explain results from group-sequential and other adaptive trials to regulators, clinicians, and scientific audiences. We unpack conditional vs. unconditional bias, median-unbiased estimation, stage-wise ordering for p-values, confidence intervals in multi-stage settings, and what to do with

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29:36

Introduction to adaptive designs and ICH E20

The Effective Statistician - in association with PSI ·

2025/10/20

In this episode, I’m joined once again by my friend and frequent guest, Kaspar Rufibach, to talk about a topic that’s been around for decades but is gaining fresh attention thanks to the new ICH E20 draft guideline—adaptive designs in confirmatory clinical trials.Kaspar and I discuss why and when we should consider adapting a clinical trial, what kinds of adaptations are statistically valid and meaningful in a regulatory context, and why these designs—despite their efficiency—are still not used as

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36:15

Leadership, Influence & Presenting: Human Skills That...

The Effective Statistician - in association with PSI ·

2025/09/29

This episode is a little different because Alun turns the microphone toward me. After 456 episodes, it feels both strange and exciting to be the “guest” on my own show. Together, we reflect on the journey so far and then dive into a topic close to both our hearts: the human skills that make statisticians and quantitative scientists truly effective.We talk about leadership as helping others accomplish something, how to influence people across functions (not just departments), why being known inside

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45:32

Top 8: The Single Arm Studies and What are the...

The Effective Statistician - in association with PSI ·

2025/09/15

I’m excited to reshare one of our most-played conversations—the one where Norwegian regulator/HTA leader Anja Schiel and I get very practical about when single-arm trials fail decision-makers and what comparative, smarter alternatives look like for regulators, HTA bodies, payers, clinicians, and—most importantly—patients.

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26:40

Top 7: How to work with a physician within Pharma to...

The Effective Statistician - in association with PSI ·

2025/09/08

As statisticians in pharma, one of the most important professional relationships we can build is with our physician colleagues. When this partnership works well, studies run smoother, decisions are better, and our impact for patients grows.In this all-time Top 7 replay, Benjamin Piske and I talk about what makes this collaboration effective, the challenges you may face, and how to establish yourself as a true partner rather than “just the statistician.”

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36:08

Top 6: What is EU HTA and why should statisticians care?

The Effective Statistician - in association with PSI ·

2025/09/01

This is one of our most downloaded episodes ever, and I’m excited to bring it back in this replay. In this conversation, I spoke with Lara Wolfson (MSD) and Anders Gorst-Rasmussen (Novo Nordisk) about EU HTA (European Union Health Technology Assessment): what it is, why it’s coming, and why statisticians like us must pay attention. If you’ve ever wondered whether your approach to safety analysis is leading to misleading conclusions, this episode is a must-listen.

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52:45

Top 5: The analysis of adverse events done right

The Effective Statistician - in association with PSI ·

2025/08/25

We’re bringing back one of our most downloaded episodes ever – a deep dive into how adverse events should be analyzed properly. This conversation with Jan Beyersmann and Kaspar Rufibach is packed with methodological insights and practical implications for statisticians working in clinical trials.Adverse event (AE) analysis has long been approached differently from efficacy analysis, often using overly simplistic methods that can bias results. In this episode, we discuss why that’s a problem – and

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42:29

Replay: R vs SAS - which is the better tool in...

The Effective Statistician - in association with PSI ·

2025/08/11

In this special replay of one of our all-time most popular episodes, we dive deep into one of the most debated topics in the pharmaceutical industry: R vs SAS.Together with Thomas Neitmann and my co-host Sam Gardner, we compare these two powerful statistical programming tools from multiple angles — ease of learning, day-to-day usability, community support, visualization capabilities, regulatory acceptance, and more. Whether you are a seasoned SAS programmer, an R enthusiast, or someone deciding

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41:35

Replay: The Chimp Paradox

The Effective Statistician - in association with PSI ·

2025/08/04

In this special replay episode — the top 3 most downloaded of all time — I’m again joined by Stuart McGuire as we explore The Chimp Paradox by Professor Steve Peters. This book provides a simple yet powerful model for understanding how our brain works — and how it often works against us if we’re not aware of it. Whether in meetings, under pressure, or dealing with self-doubt, understanding your inner “chimp” can help you manage emotions, lead with clarity, and avoid the traps that keep so many

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26:19

Replay: Is data science something for you?

The Effective Statistician - in association with PSI ·

2025/07/28

This episode ranks as the #2 most downloaded of all time—and for good reason. As data science continues to disrupt and redefine the healthcare and pharmaceutical industries, statisticians everywhere are asking: Where do I fit in? In this insightful conversation, two leaders from Cytel—Yannis Jemiai, Head of Consulting and Software, and Rajat Mukherjee, Head of Data Science—share their personal journeys from traditional statistics into data science, how the field is evolving, and why statisticians

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48:53

Replay: Things we would like to have known before we...

The Effective Statistician - in association with PSI ·

2025/07/21

This episode originally struck a chord with statisticians around the world—and for good reason. Whether you’re just starting with real-world evidence (RWE) or mentoring someone who is, this conversation is packed with practical lessons that will help you navigate the complexities of observational data with more confidence.In this special replay, guest Rachel Tham and I reflect on the real-world analysis mistakes, misconceptions, and growing pains they wish someone had warned them about earlier in

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43:32

AI and Statistics Start-ups: Opportunities and...

The Effective Statistician - in association with PSI ·

2025/06/30

In this thought-provoking keynote recording, Manjari Narayan takes us on a journey through one of the most pressing and promising intersections in modern science: the convergence of artificial intelligence, statistics, and biotechnology. Drawing on her extensive experience in both academia and biotech startups, Manjari explores the critical role statisticians can play in AI-driven drug discovery, biomarker validation, and experimental design.We are living in a "Cambrian explosion" of

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47:05

Combining RCT and RWD – applications in rare diseases...

The Effective Statistician - in association with PSI ·

2025/06/23

In this special keynote episode, I’m excited to share the recording of Professor Tim Friede’s thought-provoking presentation from The Effective Statistician Conference 2024. Tim, a leading expert in biostatistics and clinical trial design, dives deep into the combination of randomized controlled trials (RCTs) and real-world data (RWD)—especially in the context of rare diseases.Drawing from his work at the University Medical Center Göttingen and numerous European research initiatives, Tim presents

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52:00

Real-World Evidence vs. Randomized Trials: Can We...

The Effective Statistician - in association with PSI ·

2025/06/16

In this keynote episode, Professor Sebastian Schneeweiss from Harvard Medical School shares groundbreaking insights from his extensive research into emulating randomized controlled trials (RCTs) using real-world data (RWD). Recorded live at The Effective Statistician Conference 2024, this talk explores whether non-randomized studies based on electronic health records and claims data can reach conclusions as reliable as those from traditional RCTs.Prof. Schneeweiss, also Chief of the Division of

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16:32

The Power of Networking

The Effective Statistician - in association with PSI ·

2025/06/09

In this episode of The Effective Statistician, Alun Bedding takes the mic to explore one of the most underrated yet transformative tools in any professional's career—networking.With the PSI Conference happening, this episode offers timely insights into how statisticians—introverts and extroverts alike—can use networking to build meaningful professional relationships, accelerate their careers, and find support within the broader community. Alun shares personal anecdotes, including how a casual

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36:46

Inclusion for All: Rethinking Success,...

The Effective Statistician - in association with PSI ·

2025/06/02

In this episode, Alun Bedding welcomes Emma Crawford for a powerful and personal conversation about building inclusive workplace cultures—ones where every individual can thrive. Emma shares her late diagnosis of autism and how it reshaped her experience and expectations of the workplace. Together, they explore the limitations of the traditional “reasonable adjustments” framework and introduce the concept of success enablers—workplace strategies and tools that benefit not just neurodivergent

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22:57

Daily updated systematic literature reviews - the...

The Effective Statistician - in association with PSI ·

2025/05/19

How can oncologists and healthcare professionals keep up with the ever-growing body of research to make the best decisions for patients?In this episode, I speak with Anna Forsythe, a pharmacologist, health economist, and founder of OncoScope, a groundbreaking platform delivering daily updated systematic literature reviews (SLRs) in oncology. Drawing on decades of experience in pharma and health economics, Anna shares how automation and AI are transforming the traditionally tedious SLR

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35:39

A novel approach for finding predictive biomarkers

The Effective Statistician - in association with PSI ·

2025/05/12

In this episode, I’m joined by Julia Geronimi from Servier and Dr. Pavel Mozgunov from the University of Cambridge to explore a topic that’s absolutely central to advancing precision medicine—predictive biomarkers.We dive into the challenges of identifying predictive vs. prognostic biomarkers, especially in early-phase clinical trials with limited sample sizes. What makes their approach so exciting is that it offers a model-flexible, visually intuitive way to detect predictiveness—even before we

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51:48

A Webinar Recording: Redefining the Role of...

The Effective Statistician - in association with PSI ·

2025/05/05

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

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20:21

RWE and JCA - how do they go together

The Effective Statistician - in association with PSI ·

2025/04/28

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

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