Qualified Statisticians in the European Pharmaceutical Industry: Report of a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) Working Group

Regulatory guidelines assume that the responsibility for all statistical work associated with clinical trials will lie with a statistician who should be qualified by education, training, and experience to perform this task. As different European countries have widely differing educational systems and varied experiences of applying statistics in the pharmaceutical industry, it is difficult to develop a clear, unambiguous Europe-wide definition of the desired profile of such a statistician. There is a broad consensus, however, that an appropriate background would include a university degree in statistics or equivalent qualification, plus more than three years of experience in medical statistics. An example of an equivalent qualification would be a degree in mathematics or a related subject, involving more than one year (full-time equivalent) of courses in statistics. It is hoped that this outline definition will give guidance to companies, to regulatory authorities, and to individual statisticians in terms of providing statistical support to clinical trial and other pharmaceutical development activities and that it may provide a foundation for future development of the statistical profession within the pharmaceutical industry.