Discussion with Kaspar Rufibach

In this episode of "In the Interim...", Dr. Scott Berry interviews Dr. Kaspar Rufibach, Co-Head of Advanced Biostatistical Sciences at Merck. The conversation tracks Rufibach’s evolution from academic training in actuarial and mathematical statistics through cancer research collaborations, postdoctoral work, and academic consulting, leading to applied roles in Roche and Merck. Discussion centers on methodological rigor, pragmatic approaches to assurance and predictive probability, and real-world experience in drug development. Rufibach examines the organizational integration of quantitative disciplines at Merck—incorporating pharmacology, real-world data, statistics, programming, and data science—while remaining candid on the role and boundaries of AI in current pharmaceutical practice.Key HighlightsStatistical education in Switzerland, bridging theory and early applied cancer trial experienceMove from academic consulting to a trial statistician role at Roche, emphasizing structured problem-solving in drug developmentApproach to predictive probability and assurance, balancing Bayesian and frequentist tools with strict emphasis on practicalityFormation of professional special interest groups with EFSPI and PSI, stepping in to address unmet community needs rather than seeking formal leadershipPerspective on Merck’s unified quantitative department, designed to remove silos and leverage interdisciplinary expertiseCautious view of AI as a complement to specific tasks, but not yet a replacement for nuanced clinical trial design or regulatory-facing strategiesCurrent focus on expanding causal inference methods and multi-state modeling for improved trial efficiency and evidence synthesisFor more, visit us at https://www.berryconsultants.com/