TUNITIES
OPPOR
Senior Advisor for Clinical Trial Design and Analysis
Department of Health and Human Services
OFESSIONAL
PR
Food and Drug Administration/Center for Biologics Evaluation & Research
Office of Biostatistics and Epidemiology
Opening Date: March 10, 2008 Closing Date: June 20, 2008
The Department of Health & Human Services, Food & Drug Administration, Center for Biologics Evaluation and Research
(CBER) is soliciting applications for a Senior Advisor for Clinical Trial Design and Analysis. CBER is responsible for the safety
and efficacy of vaccines, the blood supply and blood products, and cellular, tissue and gene therapies that have a major impact
on public health. The candidate will provide expert advice and consultation on the design and evaluation of clinical studies and
statistical issues for biologic products and conduct and coordinate related research efforts. Candidates should have a record of
collaborative research and demonstrated ability in the design and analysis of clinical trials. The successful candidate will interact
extensively with a team of 20 biostatisticians, other FDA scientists and management, as well as leaders in other government agen-
cies, academia, and industry. He or she will represent CBER at meetings, workshops and Agency and Department discussions
concerning clinical trial matters. Excellent communication and interpersonal skills are required for this position.
CBER plays an integral role in the Department of Health and Human Services. CBER staff conducts biomedical research
to provide a strong scientific base for the regulation of blood and blood-related products, vaccines, allergenic products, and
gene therapies according to statutory authorities in order to protect and enhance the public health. In conjunction with
regulatory and research responsibilities, the Center statistically evaluates clinical and pre-clinical studies of human biological
products and vaccines and epidemiologically evaluates post-marketing studies and adverse biological reactions.
Qualifications
Candidates for Civil Service or Commissioned Corps appointments must be US Citizens.
Senior Advisor for Clinical Trial Design and Analysis, Mathematical Statistics Series, GS-1529-15
A degree that includes 24 semester hours of mathematics and statistics, of which at least 12 semester hours were in mathematics
and 6 semester hours were in statistics.
Or
Combination of education and experience—at least 24 semester hours of mathematics and statistics, including at least 12 hours
in mathematics and 6 hours in statistics, as shown in the above paragraph, plus appropriate experience or additional education.
Candidates may also be hired under Title 42
Title 42 209(g) Staff Fellow positions candidates must possess a Ph.D or equivalent degree plus two or more years of post-doctor-
al health related research/regulatory review experience. Applicants for permanent positions must hold U.S. citizenship. Non-U.S.
Citizens with permanent residency are required to provide proof with Green Card I-551.
Salary Range
GS- 15 $115,317.00-$149,000.00
Location
Rockville, Maryland
How to Apply
Submit resume or curriculum vitae with cover letter to:
FDA/CBER, 1401 Rockville Pike, Suite 200 South, Rockville, MD 20857, HFM-210
Attn: Steven Anderson
or email to:
steven.anderson@fda.hhs.gov
or fax to: 301-827-3529.
For further information please visit our website at
http://www.fda.gov/cber/inside/vacancy.htm
Department of Health and Human Services is an equal opportunity employer
Smoke free environment
54 AMSTAT NEWS APRIL 2008
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