The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

Real-World Evidence vs. Randomized Trials: Can We Emulate Accuracy?

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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 Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, walks us through the RCT DUPLICATE project, a major FDA-funded initiative that evaluated whether regulatory decisions could be replicated through high-quality real-world evidence (RWE).

From the successes to the limitations—and everything in between—this episode is packed with lessons for statisticians, regulators, and pharmaceutical leaders interested in the future of data-driven healthcare decisions.

The Power of Networking

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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 conversation with Alexander at a past PSI event led to his current guest host role, and outlines a step-by-step mindset and strategy for networking with authenticity and purpose.

Inclusion for All: Rethinking Success, Neurodiversity, and Accessibility in the Workplace

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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 individuals but everyone on the team.

The conversation dives deep into the role of leadership, AI tools, flexible work arrangements, and cultural shifts that prioritize accessibility and well-being for all employees.

Emma also previews her interactive workshop at the upcoming PSI conference and gives insight into how the session will encourage open discussion, hands-on activities, and actionable takeaways to help leaders and teams foster a more inclusive environment.

Whether you’re a people leader, statistician, or advocate for change—this episode will challenge your assumptions and inspire more inclusive practices.

Daily updated systematic literature reviews - the future of oncology

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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 process—making up-to-date evidence accessible to clinicians in just a few clicks.

Anna’s vision is clear: democratize access to high-quality, current evidence for clinicians—and ultimately improve patient care.

A novel approach for finding predictive biomarkers

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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 talk about dichotomizing biomarkers or setting cutoffs.

If you work on clinical trial design, translational science, or biomarker development, this conversation will give you fresh tools—and a lot to think about.

A Webinar Recording: Redefining the Role of Statisticians in a World of Real-World Data and AI

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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.

RWE and JCA - how do they go together

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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.

Why and how you can promote more students become statisticians

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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.

Clarifying confusions around interim, primary, final, and other analyses in clinical trial

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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.

Reimagining Clinical Trials with Synthetic Data and Digital Twins

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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 this podcast

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.

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

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