| - Ph.D. in Biostatistics
- M.B.A. in Pharmaceutical Marketing
- More than 70 publications in scientific journals
- Approximately 50 presentations at scientific symposia
- Adjunct Professor of Biostatistics, The University of Texas
- Directed (V.P. level) multinational statistics, data management, medical writing , and clinical operations organizations for several Fortune 500 pharmaceutical companies
- Directed both the strategic and operational aspects of the statistical contributions for more than 30 NDAs for new molecular entities in 11 therapeutic areas
- Directed biostatistics departments in several European countries, Latin America, Japan, and the U.S.
- Substantial Japanese experience in clinical development
- Directed all clinical operations, biostatistics, and data management for all North and South American projects for a major CRO
- FDA Comissioner’s Special Award
- PhRMA Career Achievement Award
- Chartered Statistician, Royal Statistical Society
- Fellow, American Statistical Association
- More than 35 years in the pharmaceutical industry interacting with regulatory agencies in several countries
- Personal presentations to FDA advisory committees
- Personal presentations to 5 foreign regulatory agencies
- Personal testimony to FDA Commissioner’s hearing on behalf of PhRMA
- Biostatistical consultant to the FDA while in academia
- Member of several data safety monitoring boards
- Member of steering committees for several large clinical trials.
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