Resources and Recommendations for Novice Bayesian Statisticians Working in the Pharmaceutical Industry

• Activity Number: 601
• Type: Topic Contributed
• Date/Time: Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Section on Bayesian Statistical Science
• Author(s): Stacy Lindborg*+ and Cory Heilmann*+ and Freda Cooner*+ and Matthew D. Davis*+
• Companies: Biogen Idec and Eli Lilly and Company and FDA/CDER and Clinical Theorem
• Keywords: medical product development ; bayesian ; tools ; case example ; novice

Abstract

There is an increasing need for the application of Bayesian statistical methods in medical product development. Statisticians with a frequentist background who need to adopt a Bayesian viewpoint in their work are faced with the task of finding appropriate software tools and resources which allow them to make a smooth transition from the frequentist to the Bayesian realm. We will discuss resources and recommendations which will aid statisticians in implementing Bayesian methodology when appropriate. These recommendations are based on a survey distributed to statisticians working in medical product development. We will also present a case study illustrating both frequentist and Bayesian solutions to a biopharmaceutical statistical problem. Finally, we will discuss current efforts to create a repository of case studies which will be an important resource for novice Bayesian statisticians and we will provide recommendations regarding resources that enable statisticians to adopt Bayesian methodology into their current work.