Position in Extended Committee - Regulatory and Statistical Expert
Simon is a medical statistician with around 30 years’ experience working in clinical trials. He has worked in many different therapeutic areas and has been involved in academic-run studies as well as many carried out by the pharmaceutical industry. Apart from trial expertise, he also has a lot of experience in the overall drug-development process.
For five years he was employed at the MHRA (formerly MCA) where he was Head of the Statistics Unit and (for one year) also Head of one of the therapeutic assessment units (covering toxicology, pharmacy, medical, and statistical review of Marketing Authorisation Applications). This also involved a lot of work at the European Medicines Agency, where he was vice-chair of the Scientific Advice Working Party.
He has a particular interest in orphan drugs and paediatric drug development, and was lead author for the CHMP guidance document on Clinical Trials in Small Populations. He also has interests in issues around Data Monitoring Committees and has served on several, both for industry and publicly-funded trials.
He does a lot of training on clinical trial issues and has an appointment on the teaching faculty at Johns Hopkins University, in Baltimore.
He was recently elected a Fellow of the Society for Clinical Trials.