Statogen Consulting – Dr. Stephan Ogenstad
e: sogenstad@Statogen-Consulting.com
v: (919) 761-8840
Dr. Stephan Ogenstad is President and CEO and Founder of Statogen Consulting LLC (www.statogen-consulting.com ), Wake Forest, NC, a biostatistics consulting company specializing in effective pharmaceutical design and analysis of nonclinical and clinical trials, to assist the biotechnology, pharmaceutical and medical device industries in bringing new products to market. The firm assists throughout the entire product cycle, from nonclinical to first-in-man dose-finding studies (phase I), efficacy studies (phase II), effectiveness and comparative trials (phase III) through submission.
Dr. Stephan Ogenstad was a founder and Managing Partner of Innovalyst during 2008. Dr. Ogenstad served as statistical advisor to members of the Nobel Prize committee of Medicine and Physiology, and was previously, Vice President of Biometrics at Vertex Pharmaceuticals in Cambridge, Massachusetts. 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, and worked as a professor of statistics at the Dept. of Statistics, University of Stockholm. He is a member of the International Advisory Committee of the University of North Carolina at Greensboro, and is President of the North Carolina Chapter of the American Statistical Association, and Program Chair for the section on Statistical Consulting for ASA.
Dr. Ogenstad lectured and taught courses in experimental design, drug development and in various other areas of biostatistics at the Karolinska Institute and the Swedish Academy of Pharmaceutical Sciences in Stockholm, Sweden. He is also a frequent presenter at international conferences.
Dr. Ogenstad has had numerous professional affiliations as well as society memberships. He has been the president of the Swedish Society for Medical Statistics, council member of the Swedish Statistical Association, council member and co-founder of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI), and chair of the Massachusetts Biotechnology Council, Biostatistics and Data Management.
During the past 25 years, he has held senior executive positions in nonclinical and clinical biostatistics and clinical data management with AstraZeneca, Parexel International Corporation, Amgen, and Vertex Pharmaceuticals.
Dr. Ogenstad has been the lead statistician to the filing of 14 NDA/BLA submissions in Europe, USA and Japan. He has more than 80 publications, book chapters, and presentations in the areas of biostatistics and medicine, with specialization in modeling and simulation, adaptive methods, and data and safety monitoring boards (DSMB).
