FDA Regulatory Statistician for Clinical Trial Design and Analysis Expert

Expertise

• Biostatistics: Regulation of drugs, drug devices and biologics.
• Clinical and preclinical study design and data analysis, methodological research in statistics, and computer program validation.
• Expert regulatory statistician (FDA designation).
• Areas of application include clinical trial design and analysis, interim analyses, multiple imputation, pharmacokinetics, bioavailability and bioequivalence, chemistry and manufacturing controls, stability studies (including bracketing and matrixing), animal safety studies, and carcinogenicity studies.

Expert Witness Experience

• Several projects involving scientific disputes, fraud, and FDA inspections.
• Cases: Plaintiff, (insurance company) complained that defendant (pharmaceutical company) had taken investment money when it knew it would shortly eliminate the product from its portfolio.
• Case: Adverse FDA comments on a study stimulated company Board of Directors to ask for a due diligence investigation of its management.

Experience

Undisclosed Company, 1998 - Present

President and Principal Statistical Expert

• Responsible for all executive and managerial decisions as well as technical matters.
• Areas of activity include clinical and preclinical study design and data analysis, methodological research in statistics, and computer program validation.
• Expert regulatory statistician (FDA designation).
• Areas of application include clinical trial design and analysis, interim analyses, pharmacokinetics, bioavailability and bioequivalence, chemistry and manufacturing controls, stability studies (including bracketing and matrixing), animal safety studies, and carcinogenicity studies.
• Litigation support. Clients include the largest and the smallest (virtual) U.S. biopharmaceutical firms.

Food and Drug Administration, Center for Drug Evaluation and Research, CDER, 1973 - 1998

Associate Director, Office of Epidemiology and Biostatistics, 1996 - 1998

• Responsible for drafting policy, interpreting regulations, developing standards.
• Member of the OEB management team.
• Serving as Executive Director for Information Technology for OEB.
• Principal advisor to the office, including the Director and Deputy Director, on matters pertaining to research, development, and application of information technology, scientific computing and statistical methods in evaluation of drug chemistry and drug product quality, animal toxicology, drug safety, and clinical trial data quality assurance.
• Provide scientific leadership.
• Conduct and coordinate research in statistical methodology, provide expert consultation.
• Principal, authoritative spokesperson for OEB in these areas of responsibility.

Chief, Statistical Application and Research Branch, 1979 - 1996

• Provide statistical support to all areas of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research; i.e., clinical trial evaluation for safety and efficacy of AIDS and other anti-viral drugs, biologicals, animal tumorigenicity testing, bioequivalence, epidemiology, and compendial standards.
• Responsible for directing the statistical program, for planning and allocating resources, and for the quantity and quality of work produced by three subordinate units of the Branch (18 professionals, l secretary).
• Participate in setting of short- and long-range goals for the Division of Biometrics.

Acting Director, Division of Biometrics, 1990

• Temporary promotion (6 months) while supervisor was overseas. Supervised 2 Branch Chiefs and a Division of over 50 professionals.

Group Leader, Statistical Evaluation Branch, 1976 - 1979

• First line supervisor of 5 Ph.D. level statisticians and a secretary.
• Responsible for the quantity and quality of work produced by the Group, which includes approximately 100 technical reports covering clinical trial evaluations for half the prescription drugs approved each year in the U.S.

Mathematical Statistician, 1973 - 1976

• Perform critical scientific reviews and evaluations of data and statistical methodology submitted by industry in support of new drug applications.
• Develop new methods of statistical analysis, as needed.
• Present authoritative statistical position of FDA in meetings with medical, legal and statistical personnel from industry.

Electronic Filing Services, Rockville, MD, Partner, 1987 - 1997

• Founded this company for electronic filing of federal and state income tax returns.
• Responsible for executive decisions regarding company direction, sales and marketing, and computer programming, especially for telecommunications.
• Firm filed hundreds of electronic tax returns and was profitable each year of its operation.

University of Washington, Seattle, WA, Biostatistics Department, Statistical Consultant, 1971 - 1973

• Part time while completing doctorate.

National Institutes of Health, National Heart and Lung Institute, Bethesda, MD, 1968 - 1971

Statistician (Lt., U.S. Public Health Service), Biometrics Branch

• Provide consulting services to intramural laboratory researchers involving design of experiments, data analysis by desk calculator and computer, and interpretation of results.

Honors & Publications

Credentials

• PSTAT - Accredited Professional Statistician, American Statistical Association
• Sigma Xi-RESA

Tools

• Programming in SPlus, SAS, Foxpro, Access and Excel.
• Website design in HTML and ASP.

Special Interests

• Multiple imputation
• Interim analyses
• Adaptive designs
• Forensic statistics

Languages

Speaking-fluent, conversation and writing for the following:

• English
• Spanish
• French
• Russian

Conversation

• Hebrew
• German
• Japanese (introduction)

Academic and Professional Affiliations

• American Statistical Association
• Biometric Society
• Federal Executive Institute Alumni Association
• Food & Drug Administration Alumni Association

Awards

• Harvey W. Wiley Medal and FDA Commissioner's Special Citation
• Recognition - Carcinogenicity Assessment
• Special Citation - Tobacco Working Group
• Commendation for performance as Acting Division Director
• U.S. Public Health Service Special Recognition Award
• Food and Drug Administration Commendable Service Awards
• Food and Drug Administration Award of Merit

Publications

• 1 book chapter.
• 34 papers (2 additional papers pending).
• 39 presentations given, primarily as FDA employee.

Education

• Ph.D. Biomathematics, University of Washington, WA
• M.S. Statistics, Cornell University, Ithaca, NY
• A.B. Mathematics and Statistics, University of California, Berkeley, CA