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Our Qualifications

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

  • 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

Legal Experience

  • Statistical expert in several cases
  • Provided expert testimony by deposition and at trial

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