About Us

Dr. Stephan Ogenstad is founder and President of Statogen Consulting LLC, North Carolina since 2006, Founder and Principle of Innovalyst LLC, North Carolina, and In Silico Biosciences, Inc., MA.  Dr. Ogenstad served as chief statistical advisor and reviewer to the Nobel Prize Committee for Medicine or Physiology, and was prior to 2006, Vice President of Biometrics at Vertex Pharmaceuticals in Cambridge, Massachusetts, USA.  He has 25+ years of experience with major pharmaceutical companies and distin­guished university hospitals from around the world.  Dr. Ogenstad earned a PhD in Statistics from the University of Stockholm, Sweden, and served as professor of statistics at the Dept. of Statistics, University of Stockholm.  He is an Adjunct Faculty Member and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health, Georgia Southern University, a member of the International Advisory Committee of the University of North Carolina at Greensboro, USA, is fmr President and Secretary of the North Carolina Chapter of the American Statistical Association, Program Chair for the Section on Statistical Consulting for the American Statistical Association, Member of the Clinton Health Access Initiative Clinical Advisory Board, Editor of MedCrave, Course Director of Biostatistics at Center for Professional Advancement, NJ, and President of the Swedish-American Chamber of Commerce of the Carolinas, Inc.

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Dr. Ogenstad today serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations, and is engaged in project collaborations with biotech, pharmaceutical, medical device companies, Massachusetts Institute of Technology, Georgia Southern University, and the Royal Institute of Technology, Stockholm, Sweden, where there are high-level strategy and problem solving challenges, where his expertise can become fully utilized. He is Novo Nordisk's independent statistician for the LEADER and DEVOTE studies, in type-2 diabetes. Most of the project collaborations are as an expert biostatistician in pharmaceutical, device, and biotech submissions, where strategy and statistical specialty methods, high-intensity modeling and simulation, risk analysis and decision-making strategies are critical. Dr. Ogenstad also serves as an independent statistician on Data and Safety Monitoring Boards. He interacts with FDA personnel at FDA committee meetings and FDA scientific advisory committee meetings on behalf of his clients.