The Future of Statistical Methodology in Drug Development

A Discussion with Alun Bedding and David Wright, Jürgen Hummel, and Jenny Devenport

This episode features three leading statistical methodology experts discussing the role, impact, and future of methodology groups in the pharmaceutical industry. They explore organizational structures, skill sets, AI integration, and strategies to accelerate adoption of innovative methods.

**Key topics: **

• Role and impact of methodology groups
• Organizational considerations for methodology teams
• Skills and traits of great statisticians
• Integration of AI and machine learning in pharma
• Strategies to accelerate adoption of new methods

**Episode highlights: **

• 00:00 Introduction to Statistical Methodology Groups
• 02:18 Exploring the Paper's Insights
• 06:49 The Role of Methodology Statisticians
• 10:13 Consultation and Collaboration in Drug Development
• 12:54 Addressing the Innovation Problem in Drug Development
• 16:06 Qualities of a Great Methodology Statistician
• 20:31 The Future of Methodology Groups and AI
• 25:46 The Importance of Human Insight in Clinical Trials
• 28:27 The Prevalence of Methodology Groups in the Industry
• 30:29 Goals of Methodology Departments

**Links and resources: **

• Statistical Methodology Groups in the Pharmaceutical Industry Paper Https://statistics.biopharmaceutics.com/article/10.1177/15501477221112345
• EFSPI Statistical Leaders Group https://www.efspi.org/statistical-methodology-leaders/
• EFSPI Ecosystem https://www.efspi.org/ecosystem/

**Guest links **

• Jenny Devenport: https://www.linkedin.com/in/jenny-devenport/
• David Wright: https://www.linkedin.com/in/david-wright/
• Jurgen Hummel: https://www.linkedin.com/in/jurgen-hummel/