Ph.D. in Statistics, with 20 years of applicable industry experience
Expertise in Biostatistics, Clinical Data Management, Statistical Programming, and
eTechnology across various therapeutic areas
Extensive experience of successfully building effective, innovative and dynamic biometrics
Extensive proficiency of Data and Safety Monitoring Committee functions, the
regulatory processes internationally, commercial product development and business
Dr. Stephan Ogenstad is the founder, President and Chief Executive Officer of Statogen
Consulting LLC. Prior to founding Statogen Consulting in 2006, I 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.
Have contributed to the filing of 14 NDA/BLA submissions in Europe, USA and Japan
Chairing several reputable societies and has more than 80 publications, book chapters, and
presentations in the areas of biostatistics and medicine.
EXPERIENCE IN THERAPEUTIC AREAS
Twenty years of experience in pre-clinical through Phase IV research. Therapeutic
specialization in HIV/AIDS, Central Nervous System (anti-psychotics, anti-depressives, stroke
and Alzheimer's disease), Oncology (Breast Cancer, Cervical Cancer, Leukemia, Hodgkin's
Disease, Prostate, Sarcoma, Non-small Cell Lung Cancer), Infectious Diseases (Anti-Bacterial
and CMV, HSV, HCV), Local Anesthetics and Analgesics, Cardiology, Urology, Rheumatoid
Arthritis, Neurology, and Psoriasis.
Ph.D., Statistics, University of Stockholm, Stockholm, Sweden, 1982
B.Sc., Mathematics, Statistics, Computing, University of Stockholm, 1974
L'Examen de Français Commercial de la Chambre de Commerce Française en Suède,
Business economics, University of Stockholm, 1974
Baccalaureate of Science, Stockholm’s Samgymnasium, Stockholm, 1970
G.P.A.: 4.94/5.00. The sciences stream requires a high level in mathematics, physics and
chemistry, and biology.
Swedish, English, French, German, Spanish.
Statogen Consulting LLC, Wake Forest, NC 7/ 2006-present
President and Chief Executive Officer
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Statogen Consulting offers biometrics services to assist the biopharmaceutical and medical
device industries in bringing new products to market. We assist throughout the entire product
cycle, from pre- and non-clinical to first-in-man, dose-response & dose-finding, data and safety
monitoring functions, and confirmatory clinical evaluation through submission.
Vertex Pharmaceuticals Inc., Cambridge, MA 8/ 1997-7/2006
Vice President, Biometrics, Medicines Development Group. 2005-2006
Senior Director, Biometrics, Drug Evaluation and Approval 2000-2005
Director, Biometrics, Clinical Development 1997 - 2000
Built a global strong, efficient and professional group, of currently 20 people. Implemented and
validated entirely workflow, database, electronic data capture, CDISC, adaptive designs, SAS,
and built a supercomputer simulation system in collaboration with Texas Tech University and
SAS Institute. Responsibilities include management of Clinical Data Managers, Biostatisticians
and Statistical Programmers in the entire pre-clinical, non-clinical, and clinical areas. Maintain
strong interaction with senior management on program management and improvement
initiatives. Chair of the Clinical Scientific Committee, “Rational Drug Development”, for the
enhancement of cross-functional scientific discussions, and for the betterment of study designs
and product development. Chaired the Knowledge Committee, “Knowledge Management”, for
the improvement of cross-functional knowledge exchange. Project leader for implementation,
validation, and training of MedDRA and dsNavigator. Chaired and coordinated eight cross-
departmental improvement project teams over the entire Development Division. Chair of the
EDC/CDISC Steering Committee, for the optimization of business processes through EDC and
CDISC. Leading the initiative of implementing adaptive designs of clinical trials to effectivize
clinical drug development. These initiatives have helped Vertex attain its strategic and
Amgen, Thousand Oaks, CA 8/ 1995 – 7/ 1997
Built a strong, efficient and professional group of 16 people (mostly PhD statisticians), and
gained valuable experience from the largest biotechnology company in the world.
Responsibilities included management of biostatisticians in the entire preclinical and non-clinical
area as well as in the clinical area of oncology for Neupogen. Frequently interacted with the
FDA and investigators worldwide regarding two major BLAs.
PAREXEL International Corporation, Waltham, MA 8/ 1993 – 7/ 1995
Vice President, Biostatistics and Data Management Division 1994-1995
Served on a corporate level to restructure the corporation worldwide, after which the company
grew 10-fold. Set long-term goals and objectives and developed performance metrics to track
the progress of objectives. Supervised up to five directors and a staff of 220 people. Coordinated
statistical, programming, and CDM activities, as well as lead cross-functional activities with
other divisions within the company. Established and documented department standard operating
procedures with continual evaluation of systems improvement. Served as a technical advisor to
staff, clients, and other divisions in the company worldwide. Frequently represented clients at
meetings with the FDA. Traveled frequently across the US and Europe to meet with new clients
and attract new business.
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Director, Biostatistics and Data Management Division 1993 – 1994
Coordinated cross-functional activities and improvements within the company. Represented the
company in numerous client meetings. Establish and document department standard operating
procedures with continual evaluation of systems improvement. Prepared proposals, including
time estimates and general assumptions, to clients. Served as a technical advisor to staff, clients,
and other divisions in the company worldwide. Frequently represent the clients at meetings with
AstraZeneca (former Astra), Stockholm, Sweden 8/ 1982 –7/ 1993
Director, Biostatistics 1987-1993
Managed and mentored 12 biostatisticians and programmers on consulting on protocol design,
data collection and management, statistical analysis and statistical reporting, reviewing reports
and contributing overall to the submission of 11 NDAs. Worked as the Biostatistics liaison,
transferring projects to Merck Sharp and Dohme, PA, USA. Involved in development and
application of standard operating procedures within AstraZeneca worldwide. Frequently met
with regulatory bodies and investigators worldwide.
Senior Biostatistician 1982 - 1987
Project biostatistician in pre- and non-clinical, toxicology, and all phases of clinical drug
development; including development of study protocols, analysis plans, CRFs, data review
guidelines, programming, statistical analysis and statistical reporting, reviewing reports and
contributing overall to the submission of NDAs. Frequently met with regulatory bodies and
University of Stockholm, Department of Statistics 11/ 1974 – 7/ 1982
Lecturer and Professor of Statistics
Lecturing in graduate and post-graduate courses in Probability Theory, Inference Theory,
Regression & Analysis of Variance, Time Series Analysis, Sampling Techniques, Dynamic
Programming, Epidemiology, and Econometrics. Conducted research in the field of survival
Silico Insights, Inc., Woburn, MA
Senior Scientific Advisor 1/ 1999 – 12/ 2001
Served as an advisor on scientific and business issues during the formation of an informatics
company. Silico Insights' technology platform addresses the urgent needs in information
processing of researchers and executives in the pharmaceutical, biotechnology and the
Senior Statistical Advisor to members of the Nobel Prize Committee of Medicine and
Physiology, 1975 - 1982.
Lecturer at Karolinska Institute, Stockholm, in medical statistics 1974 - 1982.
Consulting Statistician and Programmer at Roche, Hoechst, Essex, Pharmacia, The
Wellcome Foundation Ltd., Karolinska Institute, Karolinska Hospital, Radiumhemmet,
Huddinge Hospital, Danderyd Hospital, Söder Hospital, Serafimer Hospital, Sahlgrenska
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Hospital, Swedish Bacteriological Laboratory, and Swedish Board for Technical
Development. The Group for Applied Statistics, Stockholm, 1975 - 1982.
Lecturer at the Swedish Academy of Pharmaceutical Sciences in statistical clinical trials
methodology, 1982 - 1993.
Lecturing at various research units and marketing companies worldwide within AstraZeneca
in "Clinical Trials Methodology from a Statistical Point of View" (a one-week course for
Clinical Research Scientists), 1983 - 1993.
Presenter at various conferences worldwide, 1976 - present.
Extensive training in leadership, software systems, therapeutic areas, and statistics (list
Statistical Packages: SAS, S-PLUS, GLIM, BMDP, MATHEMATICA, RS/1, MINITAB,
STATXACT, LOGXACT, EAST 4, PEST, MAPLE 10, Trial Designer, ACSL, XPRO
Database Experience: Oracle
Programming Languages: Fortran, Cobol, Basic, RPL, JCL, SQL
Word Processing, Spreadsheets and Specialty Packages: Microsoft Word, Microsoft Excel,
ClarisDraw, Meeting Maker XP, Adobe Persuasion, Wordmark, WordPerfect, AmiPro,
Elected Program Chair of the section “Statistical Consulting” of ASA for 2009
Reviewer of Statistics in Medicine
2007 Elected Vice President of the North Carolina Chapter of the American Statistical
Member of the International Advisory Committee of the University of North Carolina at
2008 Elected President of the North Carolina Chapter of the American Statistical Association.
Chair of Massachusetts Biotechnology Council, Biostatistics and Data Management, 1997 to
Reviewer to SAS Institute, 1996 to present
Statistical reviewer of Applied Clinical Trials, 1996 to 1998
President of the Swedish Society for Medical Statistics, 1991 - 1993
Council member of Swedish Statistical Association, 1991 - 1993
Council member and co-founder of European Federation of Statisticians in the Pharmaceutical
Industry, 1991 - 1993
Member of ISCB - Working Party on Statistics in European Drug Regulation, 1991 - 1993
Member of the Adverse Event Management Group in Coordination of AstraZeneca's Clinical
Information Systems, 1992 - 1993
Member of Guideline for the Internal Statistical Report Group, 1990 - 1993
Member of AstraZeneca Evaluation Planning Team, 1993
Member of World-wide Quality of Life and Health Economics Task Force between AstraZeneca
and Merck/US, 1991 - 1993
Chair of Clinical Trials Methodology from a Statistical Point of View, 1983 - 1993
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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.
1999, 2000, 2001 Professional Mentor Recognition Award, School of Public Health and Health
Sciences, University of Massachusetts
PUBLICATIONS AND PRESENTATIONS
More than 80 publications and presentations (list available).
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