
Douglas Milikien
Founder and Principal Consulting Biostatistician, Accudata Solutions, Inc. Biostatistical expert with over 25 years of executive-level experience in planning and supporting various phases of pharmaceutical, medical device, and diagnostic product development.
About this speaker
Doug holds a Master’s Degree in Biostatistics, a Master’s Degree in Demography, and a Bachelor’s Degree in Statistics, all from the University of California, Berkeley. With over 25 years of experience in pharmaceuticals, medical devices, and diagnostics, Doug began his postgraduate career as a Research Statistician at the Northern California Alzheimer’s Disease Center. After two years at a statistical consulting firm, he founded Accudata Solutions in 1991. Throughout his career, Doug has been involved in 10 regulatory submissions, taking on leadership roles in 4 PMA submissions, 1 NDA approval, and one 510(k) approval.
Additionally, Doug has served as a voting member of a Data Safety Monitoring Board and has acted as an instructor for pharmaceutical scientists at the Institute for International Research, as well as an in-house instructor for Bayer Pharmaceutical's Biotechnology Division. He is also the author of numerous peer-reviewed articles and has presented at conferences for the American Statistical Association, the American Society for Quality, and the Parenteral Drug Association.