Dr. Simon Day

Clinical Trials Consulting & Training, CEO

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He specialises in training and consulting on drug development programmes, scientific advice/end of Phase II meetings and preparations for oral explanations and advisory committees. He is particularly well known for his work in the area of developing treatments for rare diseases.

He is a former president of the International Society for Clinical Biostatistics.  He is joint editor of Statistics in Medicine, on the editorial board of Translational Sciences of Rare Diseases, and has previously served on many other editorial boards. In 2012 he was elected a Fellow of the Society for Clinical Trials. He has published widely in statistical and medical journals, is author of one book “Dictionary for Clinical Trials” and is joint editor of the “Textbook of Clinical Trials”, both published by Wiley.

Simon has served on a variety of data monitoring committees both for industry-sponsored and government-sponsored trials. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He formerly served as vice-Chairman of the West London Research Ethics Committee. He has given numerous lectures and courses on statistics and clinical trials all around the world, including courses at the FDA on the development and regulatory assessment of orphan drugs.