Podcast Episode
82: Statistical Methodology Groups in the Pharmaceutical Industry
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Scott Berry, Ph.D.
President & Senior Statistical Scientist
In this episode of "In the Interim…", Scott Berry is joined by Jenny Devenport and Kaspar Rufibach of Merck Group, co-authors of the EFSPI Statistical Methodology Leaders paper "Statistical Methodology Groups in the Pharmaceutical Industry," and May Mo of Amgen, a co-author of the commentary on the paper from the Statistical Innovation Community, an ASA Biopharmaceutical working group.
In this episode of "In the Interim…", Scott Berry is joined by Jenny Devenport and Kaspar Rufibach of Merck Group, co-authors of the EFSPI Statistical Methodology Leaders paper "Statistical Methodology Groups in the Pharmaceutical Industry," and May Mo of Amgen, a co-author of the commentary on the paper from the Statistical Innovation Community, an ASA Biopharmaceutical working group. The guests describe methodology groups within a pharmaceutical company as a strategic investment, and innovation as the product of invention and commercialization, where publication, regulatory dialogue, and validated software ("statistical engineering") turn new methods into common practice. They discuss why new mechanisms of action and therapies such as CAR-T need more than a t-test or a log-rank test, and how estimands, causal inference, adaptive designs, and external data borrowing are reaching clinical trial statistics. The conversation addresses the concern that a dedicated group divides methodologists from project statisticians, how these groups demonstrate their value, why quantitative decision-making is a core competence of a pharmaceutical company, and why curiosity and collaboration matter as much as technical skill.
Key Highlights
Innovation as the product of invention and commercialization, and the role of methodology groups in scaling new methods.
New mechanisms of action, from delayed immune activation to CAR-T, that a t-test or log-rank test cannot handle.
Estimands, causal inference, adaptive designs, and external data borrowing entering clinical trial statistics.
Avoiding a divide between methodologists and project statisticians, and why there is "no unicorn statistician."
Showing value to leadership, from study involvement and due diligences to gains in probability of success.
Quantitative decision-making: presenting design options with their risks, costs, and trade-offs.
Curiosity, collaboration, and communication as the traits of an influential methodologist.
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82: Statistical Methodology Groups in the Pharmaceutical Industry
In this episode of "In the Interim…", Scott Berry is joined by Jenny Devenport and Kaspar Rufibach of Merck Group, co-authors of the EFSPI Statistical Methodology Leaders paper "Statistical Methodology Groups in the Pharmaceutical Industry," and May Mo of Amgen, a co-author of the commentary on the paper from the Statistical Innovation Community, an ASA Biopharmaceutical working group.
81: A Discussion on Virtual Controls
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80: Clinical Trial Arenas: Direct Communication to Patients
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79: Science Coaching With Alun Bedding
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78: The CHIPS Trial: Bayesian Adaptive Trial in JAMA
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69: Fairness in Soccer and Clinical Trials
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68: Bias in Stopping Trials Early
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67: A Statistician Reads JAMA: A Futile Issue
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60: AI @ Berry
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55: A Visit with Stephen Senn: Time, Concurrent Controls, and the Bayesian Guidance
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53: The SNAP Trial with Professors Tong and Davis
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52: Bayesian Borrowing in Phase 3 Trials
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51: The Art of Storytelling with Shaun Cassidy
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50: The Fallacy of Ordinal Endpoints
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49: Mr. Berry Goes to Washington
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47: A Visit with Michael Harhay
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46: The FDA Bayesian Guidance
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44: Statistical Communication
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43: The Rumor of One Trial for Substantial Evidence
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42: Communication for Scientists: A Discussion with Jenny Devenport
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34: Digital Googols
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32: Moving Clinical Trial Goalposts
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31: The Not So Promising Zone Design
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30: A Visit with Dr. Janet Wittes
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28: A Visit with Dr. Derek Angus
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26: Discussions on the ICH E20 Draft Guidance
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20: The Legend of I-SPY 2 - Part A
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18: A Statistician Reads JAMA
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17: Seamless 2/3 Trial Designs
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16: Spending Alpha
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14: Drug Developers' Lessons from Sports: Regression-to-the-Mean
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13: DSMBs in Adaptive Trials with Roger Lewis
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7: Remembering Jimmie Savage
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6: The Art and Slog of Innovating
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5: Religion, Politics, and Ordinal Outcomes
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2: When should you use adaptive design clinical trials?
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1: The story of Berry Consultants
Discover the transformative journey of Berry Consultants, pioneers in adaptive clinical trials, and their impact on the future of medical research.