DORER STATISTICAL CONSULTING

Biographical Sketch

David J. Dorer, Ph.D. has over twenty five years of experience as a Biostatistician in both industry and hospital based research. At Ariad Pharmaceuticals he designed and analyzed multisite worldwide Phase I/II/III clinical trials and served on the Safety Management Teams for two oncology compounds. He provided statistical support to the Ponatinib and Brigatinib drug development programs, from first in man through marketing approval. He has extensive worldwide experience with FDA New Drug Applications (NDA), EMA Marketing Authorization Applications (MAA), and post-marketing regulatory safety filings. Dr. Dorer also served as the statistician member of the Ariad clinical pharmacology research group.

Prior to his time at Ariad, Dr. Dorer worked as a biostatistician at the Massachusetts General Hospital Biostatistics Center. As part of his activities at MGH, he designed and analyzed National Institutes of Health Phase III clinical trials and worked on a long term follow up study of Eating Disorders sponsored by the NIH. He evaluated outcomes of surgical operations and the effects of the reduction in hospital residents' work hours. He served as a statistician on the MGH Biostatistics Center Clinical Research Program consulting service.

Dr. Dorer has experience in a broad range of medical specialties including: oncology, neurology, surgery, infectious disease, intensive care, pediatrics, rehabilitation medicine, psychiatry, endocrinology and cardiology.
He was the statistician member of several clinical trial Data Safety Monitoring Committees during his time at MGH.

Dr. Dorer has co-authored over fifty peer-reviewed publications. He received his undergraduate and graduate education at Massachusetts Institute of Technology, and completed a post-doctoral fellowship at Harvard University & NASA Ames Research Center.