Sr. Biostatistician – FDA Regulatory Reporting
Description:
Work with senior biostatistics and clinical development teams to
design and conduct, evaluate, interpret and prepare results of
clinical studies. Develop methodolody for statistical analysis and
generate study randomization. Determine analysis and data presentation
specifications for programmer analysts and statisticians. Perform
analysis, interpret study results, collaborate with medical and
biostatistics staff to produce reports, and publications. Represent
the biostatistics function on project teams. Interact with FDA staff
to ensure drug studies meet FDA requirements. Attend meetings with FDA
on project development, collaborate with medical and biostatistics
staff to produce reports for the application to the FDA. This position
supports the development of various medical treatments.
Requirements:
Minimum requirements: are a Ph.D. in Biostatistics or closely related
discipline and at least two years experience, or a Master's Degree in
Biostatistics and four years experience in the support of clinical
studies, preferably in a pharmaceutical industry or clinical studies
unit setting. Sol id experience in statistical experimental designs
and analyses, clinical trial requirements and statistical software
packages such as SAS and S-PLUS. Strong interpersonal and effective
communication (oral and written) skills. Pharmaceutical or closely
related industry experience. Experience with Phase I - III clinical
trials or studies in support of U.S. PLAs/NDAs
Email resume for immediate consideration, or for further information
please contact:
Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) [EMAIL PROTECTED]
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