Stephan Ogenstad

Current

Founder and Affiliate of Innovalyst at Innovalyst
President & CEO at Statogen Consulting (sogenstad@Statogen-Consulting.com)

Past

Vice President, Biometrics at Vertex Pharmaceuticals, Inc.
Manager at Amgen
Vice President at Parexel International

3 more...

Education

Stockholms universitet

Recommended

11 people have recommended Stephan

Connections

500+ connections

Industry

Biotechnology

Websites

Stephan Ogenstad’s Summary

Dr. Stephan Ogenstad is President and CEO and Founder of Statogen Consulting (www.statogen-consulting.com ), Wake Forest, NC, a biostatistics consulting company.

Dr. Ogenstad was a founder and Managing Partner of Innovalyst during 2008. He served as statistical advisor to members of the Nobel Prize committee of Medicine and Physiology, and was previously, VP of Biometrics at Vertex Pharmaceuticals in MA. 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, 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 UNC at Greensboro, and is President of NC Chapter of the American Statistical Association, and Program Chair for Statistical Consulting for ASA.

He lectured in experimental design, drug development and in 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 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 CDM with AstraZeneca, Parexel International Corp, Amgen, and Vertex Pharmaceuticals.

Dr. Ogenstad was the lead statistician to the filing of 14 NDA/BLA submissions in Europe, USA and Japan. He has more than 80 publications, books, and presentations in biostatistics and medicine, with specialization in M&S, adaptive methods, and data and safety monitoring boards (DSMB).

Stephan Ogenstad’s Specialties:

Statistical representation at FDA EMEA; process innovation; Expert clinical statistics; statistics for medical devices; coaching; alliances; networks; internet; regulatory; negotiation; IT; methodology review; Analysis interpretation; Report review; Statistical reports; SAP; Exploratory analysis; Modeling simulation; Non- & preclinical consulting; Training (Clinical Trials Methodology, Biostatistics, Adaptive designs, GCP); Programming; CDM; wireless; Off-shoring and cost rationalization

Stephan Ogenstad’s Experience

Founder and Affiliate of Innovalyst

Innovalyst

(Biotechnology industry)

May 2008 — Present (1 year 3 months)

Training and coaching
1. STATISTICS FOR NON-STATISTICIANS [½-day; 1-day; 2-days; 3-days]
2. THE NDA GAME WORKSHOP [2-day workshop]
3. LEADERSHIP [2-day workshop]
4. ADAPTIVE CLINICAL TRIALS METHODS [1-day ]
5. PROJECT MANAGEMENT [½-day; 1-day; 2-days; 3-days]
6. EXCELLENCE IN SCIENCE [ACCELERATOR/INCUBATOR]
7. FUSING SCIENCE, TECHNOLOGY AND INDUSTRY LEADERSHIP [½-day; 1-day; 2-days; 3-days]
8. GOOD CLINICAL PRACTICE [½-day; 1-day]
9. REGULATORY AFFAIRS IN THE US: AN OVERVIEW OF REGISTRATION PROCEDURES FOR THE FDA [½-day; 1-day]
10. HOW TO PREPARE FOR AN FDA GCP AUDIT [½-day; 1-day]
11. REGULATORY AFFAIRS IN THE EUROPEAN UNION: AN OVERVIEW OF REGISTRATION PROCEDURES FOR MEDICINAL PRODUCTS IN EU [½-day; 1-day]
12. MATHEMATICAL MODELING AND TRIAL SIMULATION IN MEDICINE AND LIFE SCIENCES [1-day; 2-days]
13. DESIGN CONTROL & DOCUMENTATION [1-day, 2-days]
14. QUALITY ASSURANCE [1-day]
President & CEO

Statogen Consulting (sogenstad@Statogen-Consulting.com)

(Privately Held; 1-10 employees; Biotechnology industry)

August 2006 — Present (3 years)

Dr. Stephan Ogenstad is the founder, President and Chief Executive Officer of Statogen Consulting LLC. Prior to founding Statogen Consulting in 2006, Dr. Ogenstad held the position as Vice President of Biometrics at Vertex Pharmaceuticals Incorporated in Cambridge, Massachusetts, and prior to Vertex held senior managerial positions at Parexel International, Amgen, and Astra. Dr. Ogenstad has the reputation of being very innovative and dynamic in the field of eTechnology, statistical methods, and strategy in drug development. He has contributed to the filing of 13 NDA/BLA submissions in Europe, USA and Japan, is chairing several reputable societies and has more than 80 publications, book chapters, and presentations in the areas of biostatistics and medicine.

Stephan Ogenstad’s Education

Stockholms universitet

PhD , Statistics , 1970 — 1982

Activities and Societies:

• Senior Statistical Advisor to members of the Nobel Prize Committee of Medicine and Physiology, 1975 - 1982.
• Lecturer in Probability, Inference, Regression & ANOVA, Time Series, Sampling, Dynamic Programming, Epidemiology, and Econometrics.
• Lecturer at Karolinska Institute, Stockholm, in medical statistics 1974 - 1982.
• Lecturer at Karolinska Institute, Stockholm, in medical statistics 1974 - 1982.

Additional Information

Stephan Ogenstad’s Websites:

Stephan Ogenstad’s Interests:

• Program development advise, strategy and consulting phases I-IV • Statistical representation and presentation to regulatory authorities (FDA, EMEA) • Data and Safety Monitoring Board (DSMB) interim analysis planning and statistical support • Clinical process innovation - trial design and trial conduct • Clinical trial design, simulation and monitoring system, through adaptive design and analysis • Expert statistical support for individual studies and programs • Statistical methodology review • Analysis interpretation • Report review

Stephan Ogenstad’s Groups:

Reviewer of Statistics in Medicine. 2008 Elected President of the North Carolina Chapter of the American Statistical Association. American Statistical Association, Swedish Statistical Association, Swedish Society for Medical Statistics, International Society for Clinical Biostatistics, Biometric Society, Drug Information Association, Swedish Epidemiological Society, European Federation of Statisticians in the Pharmaceutical Industry, International Neural Network Society, European Organization for Quality, Swedish Association for Quality, Mathematical Association of America, American Association of Pharmaceutical Sciences, Interface., Tecnalia, InterFrench, Worldwide Management Consultants, Swedish, Digital Pen and Paper Society, French Connection