New Paradigms for Statistical Support in Pharmaceutical R&D
*Dennis Cosmatos, Strategic Statistical Consulting 

Keywords: Pharmaceutical, new paradigm, statistics, biostatistics

Statisticians who have been working in Pharmaceutical R&D have seen many changes occurring in drug discovery, development, registration and marketing processes. It is time for us to recognize the duties of the statistician also need to change in order to adapt to these changes in this industry. What will be discussed is a new proposed paradigm of a “translational” statistician that focuses on knowing a broad set of available analyses, and with proper understanding of the clinical and/or scientific characteristics of the data and decisions to be made from those data, that “translates” all this to allow selection of an optimal study design, analysis approach and results display to be used. Then, working with an academic colleague who is an expert in the selected method, an optimal analysis is performed. Educational needs for creating "translational" statisticians will also be discussed.