The development of safe, efficacious and cost effective medicines and medical devices requires<br>dedicated teams of people with diverse backgrounds including all manner of the sciences,<br>regulatory affairs, marketing, health economics and so on. Statistics and statisticians also have<br>an integral role in the drug development industry. In fact, it is probably one of the few industries<br>where there is a regulatory requirement that statisticians MUST be involved in each project from<br>the design of an experiment through to the report. The life cycle of a medicinal product, focusing<br>on the statistical needs of various team members and others exposed to the product will be<br>described to understand the range of statistical skills required by the various disciplines within<br>the pharmaceutical, medical device and biotechnology sectors.
The CAUSE Research Group is supported in part by a member initiative grant from the American Statistical Association’s Section on Statistics and Data Science Education