The objective of this presentation is to provide an introduction to the pharmaceutical industry, the roles statisticians play in the industry, and some real examples encountered in clinical trials.

Drug development is a long and costly process.  Much of the investment is in the clinical development stage, where statisticians make critical contributions.  To be effective, statisticians have to be able to collaborate well with medical colleagues, data management professionals and programmers.  Different knowledge and skill sets are required to support clinical studies in the 4 different phases.

Examples are provided to illustrate the statistical issues in clinical trials.