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William R. Fairweather, PhD, PSTAT(R)
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1998
to Present
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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.
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Center
for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Rockville MD 20857
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1996 to 1998
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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.
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1979 to 1996
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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.
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1990
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Acting Director, Division of Biometrics
Temporary promotion (6 months) while supervisor was overseas. Supervised 2
Branch Chiefs and a Division of over 50 professionals.
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1976 to 1979
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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.
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1973 to 1976
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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.
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1987 to 1997
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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.
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1971 to 1973
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Statistical Consultant.
Biostatistics Department, University of Washington,
Seattle, Washington.
Part time while completing doctorate.
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1968 to 1971
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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.
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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
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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
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American
Statistical Association ACCREDITED PROFESSIONAL STATISTICIAN(R)
Biometric Society
Regulatory Affairs Professional Society
Federal Executive Institute Alumni Association
Food & Drug Administration Alumni Association
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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 Rockville.
I program in SPlus, SAS, Foxpro, Access, 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.
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