The pharmaceutical industry is a major source of career opportunities for statisticians in today's market. A statistician in this industry has the potential to make significant contributions along the pathways of discovery and development that, when traversed successfully, bring molecular entities to the marketplace. The objectivity that statisticians are trained to bring to a problem can be particularly valuable in an industry where so much is at stake based on the outcomes of studies. The role of the statistician varies at the different stages of product development and may differ substantially from the role served on a research study being carried out in a non-regulatory environment. A brief overview of the drug development process will be provided in this seminar, with particular emphasis on the statistician's involvement in the process. Examples of statistical issues that are frequently encountered in drug development and ways of addressing them will also be discussed briefly. This seminar is intended as an introduction to a graduate level course on statistical issues in pharmaceutical research, to be offered during the spring semester of 2004 by the Statistics Department at NCSU. The objectives of the course are to inform the statistics graduate student about careers in pharmaceutical research, whether at a product development company, a contract research organization, or a regulatory agency, and to provide additional training in statistical issues particularly relevant to this area as preparation for such a career.
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