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
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