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William R. Fairweather, PhD, PSTAT(R)

 

1998 to Present

President, Flower Valley Consulting, Inc.

15405 Narcissus Way

Rockville MD 20853

 

Principal in this statistical consulting firm.  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.

 

Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Rockville MD 20857

 

1996 to 1998

Associate Director, Office of Epidemiology & Biostatistics

Responsible for drafting policy, interpreting regulations, developing standards. Member of the OEB management team. Also 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.

 

1979 to 1996

Chief, Statistical Application & Research Branch

Provide statistical support to all areas of the Center for Drug Evaluation & Research and (until 1990) the Center for Biologics Evaluation & Research; ie, 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.

 

1990

Acting Director, Division of Biometrics

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

 

1976 to 1979

Group Leader, Statistical Evaluation Branch

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.

 

1973 to 1976

Mathematical Statistician

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.

 

1987 to 1997

Partner

Electronic Filing Services
Rockville Maryland
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.

 

1971 to 1973

Statistical Consultant.

Biostatistics Department, University of Washington,
Seattle, Washington.
Part time while completing doctorate.

 

1968 to 1971

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

Biometrics Branch, National Heart and Lung Institute,
National Institutes of Health, Bethesda, Maryland.
Provide consulting services to intramural laboratory researchers involving design of experiments, data analysis by desk calculator and computer, and interpretation of results.

 

PhD, Biomathematics, University of Washington, l973
MS, Statistics, Cornell University, l966
AB, Mathematics and Statistics, University of California,
Berkeley, l964


Research interests:
Multiple imputation
Interim analyses
Adaptive design
Forensic statistics

 

Harvey W. Wiley Medal and FDA Commissioner's Special Citation "for outstanding and sustained application of statistical methodology in the areas of postmarketing risk assessment, carcinogenicity, and animal toxicology with the aim of promoting public health." 1999

Group Recognition Award for service on Carcinogenicity
Assessment Committee, 1997
Commissioner's Special Citation for service on Tobacco Working Group, 1994
Commendation for performance as Acting Division Director, 1991
US Public Health Service Special Recognition Award, 1987
Food and Drug Administration Commendable Service Awards, l980 and 1983
Food and Drug Administration Award of Merit, l976
Sigma Xi-RESA, l975
Listed in Who's Who in American Science
U.S. Public Health Service NIH Predoctoral Fellow, University of Washington, l970-l973
John McMullen Graduate Fellow, Cornell University, l964-5
A.B. with Honors, University of California, l964

 

American Statistical Association ACCREDITED PROFESSIONAL STATISTICIAN(R)
Biometric Society
Regulatory Affairs Professional Society
Federal Executive Institute Alumni Association
Food & Drug Administration Alumni Association

 

I enjoy a number of activities in addition to my professional work. Among these are aikido, linguistics, and sailing. I hold a sandan (3rd degree black belt) in aikido and I teach at the Maryland Ki Society in Olney Maryland.

I program in R, SPlus, SAS, Access, and Excel. I have created a website using HTML and ASP. In addition to English, I speak French and Hebrew, I understand some Spanish and German. I am studying Japanese.

I am a longtime sailor, and I own a 2003 ComPac 35 sloop. My wife and I sail her primarily in Chesapeake Bay. In the fall of 2007 and again in 2010 we travelled down the IntraCoastal Waterway to Florida on our boat. We live and work aboard in the winter and we return to Chesapeake Bay in the spring. In the spring of 2011 we cruised her to the Bahamas. We are not new to ocean sailing. We joined our son, Brian in Tahiti in July 2000 during his South Pacific cruise and accompanied him as far as Tonga (1500 miles).

I have served as a referee for the National Academy of Sciences/National Research Council and for the journal Statistics in Biopharmaceutical Research. I have contributed to a Wikipedia article.

I am currently mentoring two junior statisticians.

 

 

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