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Academic Qualifications

  • 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

Industry Experience

  • 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

Honors/Awards

  • 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

Regulatory Experience

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  • 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

Legal Experience

Our Qualifications

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