Statistics in Drug Development: A Personal Perspective
In this talk, I want to give the audience an idea of what the work of a statistician in a pharmaceutical company might look like using my own experiences. I will give two examples of applied statistics during drug development: an innovative strategy for a dose-ranging trial (MCPMod) and the estimation of the probability of success of a phase 3 trial given the mechanism of action of a compound for cardiovascular risk reduction. Emphasis will be on the strategic context of statistical methods within clinical drug development and on desirable skill-sets that help statisticians in the industry to succeed. I will conclude with some general comments that might be helpful for graduate students considering working in the pharmaceutical industry.