The Effective Statistician - in association with PSI

Generative AI is moving fast—and in pharma, it’s no longer just a buzzword. In this episode of The Effective Statistician Podcast, I speak with Manuel Cossio about how Generative AI is already being applied in real-world pharma settings, where it’s delivering value today, and what still needs careful consideration in regulated environments.

Manuel brings a unique hybrid background, combining molecular biology, genetics, pharma experience, and deep AI engineering expertise. He works at the cutting edge of AI in clinical development, including agentic systems, human-in-the-loop approaches, and large-scale document automation.

This conversation goes well beyond theory. We focus on practical use cases, real limitations, and how statisticians, programmers, and data scientists can responsibly use GenAI to become more effective.

As we start 2026, I want to take a moment to express my sincere gratitude to everyone who has been part of The Effective Statistician podcast. This episode features my co-host, Alun Bedding, reflecting on the past year and sharing thanks on behalf of both of us.

From our listeners who tune in, share episodes, and engage with the content, to our guests who generously share their expertise and real-world experiences — your participation makes this podcast both insightful and practical for statisticians worldwide.

I also want to recognize Reine and her production team. So much of the work that brings each episode to life happens behind the scenes, and we are deeply grateful for their professionalism and dedication.

We’re excited about what 2026 has in store. I look forward to continuing this journey with all of you and bringing even more valuable conversations to our community.

In this episode, I talk with my long-time friend and frequent guest, Kaspar Rufibach, about a skill that quietly determines how much impact we really have: presenting and communicating our work.

We walk through how Kaspar prepares his talks (including why he starts months in advance), how he structures messages so stakeholders actually remember and act on them, and why overcrowded slides are often just a sign that we haven’t done the hard thinking yet.

We also get honest about something many statisticians feel but rarely discuss: the fear of public speaking, the frustration of bad meetings, and the “personal brand” you build every time you present—whether you intend to or not.

If you’ve ever walked out of a meeting thinking “I don’t think they really understood what I meant,” this episode is for you.

In this episode, I’m joined by Deepa Jahagirdar, Associate Research Principal at Cytel, to explore what it really takes to build a good external control arm (ECA). Deepa brings a fascinating background from social epidemiology, where causal questions often need to be answered without running randomized trials. That experience translates directly into today’s growing need for ECAs, especially when we rely on real-world data to support single-arm trials, extension phases, or situations where randomization simply isn’t possible.

Together, we discuss how to choose the right data source, how target trial emulation works in practice, what to do about confounding, and how to judge whether an ECA is truly robust. If you’re working with real-world evidence, complex study designs, or causal inference, this episode will give you clarity and confidence in approaching ECAs the right way.

Why this episode made our all-time Top 9: If you’ve ever thought “non-parametric = Wilcoxon/Mann-Whitney and that’s it,” this conversation will happily destroy that myth. Frank shows how rank-based methods unlock rigorous analyses for skewed data, outliers, ordinal endpoints, small samples, composites/estimands—and how to communicate effects without relying on means.