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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