- 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 and Public Health, The University of Texas School of Public Health
- Directed (V.P. level) multinational statistics, data management, medical writing, and clinical operations organizations for several Fortune 100 pharmaceutical companies
- While working in the pharmaceutical industry, 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 and clinical operations departments in several European countries, Latin America, Japan, and the U.S.
- Possess substantial Japanese experience in clinical development
- Directed all clinical operations, biostatistics, and data management for all North and South American projects for a major contract research organization
- FDA Commissioner's Special Citation
- PhRMA Career Achievement Award
- Accredited Professional Statistician (PStat), American Statistical Association
- Chartered Statistician, Royal Statistical Society
- Fellow, American Statistical Association
- More than 35 years in the pharmaceutical and biotechnology industries interacting with regulatory agencies in several countries
- Personal presentations to FDA advisory committees
- Personal presentations to the regulatory agencies of 10 countries
- Personal testimony to FDA Commissioner's hearing on behalf of PhRMA
- Participated in the FDA training program for advisory committee members
- Member of several data safety monitoring committees
- Member of steering committees for several large clinical trials
- Statistical expert in several cases
- Provided expert testimony by deposition and at trial
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