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Job Title: Associate Director Biostatistics
Job Location: CA: San Francisco
Pay Rate: Open
Job Length: full time
Start Date: 2008-03-31
Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856
Description: Associate Director of Biostatistics will lead a
biostatistics group in sup****t of clinical development for one or more
therapeutic areas. Responsible for the statistical input provided by the
group to all major do***ents, including clinical development plans,
protocols, clinical study re****ts, summaries of clinical safety and
efficacy, and other sections of BLAs. Advise Biostatisticians on
technical issues associated with the design, performance, and analysis of
clinical trials. Provide review and guidance to Biostatisticians on
statistical aspects of all FDA interactions, including FDA meetings,
responses to FDA questions, and Advisory Committee Meetings. Work closely
with Therapeutic Area management in defining strategic approaches to
clinical trials and in meeting operational requirements of development
plans. Provide leader****p to therapeutic area Biometrics management team.
Maintain comprehensive knowledge of theoretical and applied statistics and
regulatory guidelines regarding clinical trial analysis and re****ting.
Apply new statistical procedures as appropriate. Responsible for line
management for a group of Biostatisticians in one or more therapeutic
areas, including setting employee goals and doing performance reviews.
Ability to effectively collaborate, communicate, and influence all levels
of the organization. BLA/NDA development and submission experience
required. Comprehensive understanding of theoretical and applied
statistics as well as regulatory guidelines in a pharmaceutical research
setting is necessary. Extensive experience in clinical trials is also
necessary. A PhD with at least 8 years pharmaceutical experience, with
at least 2 years experience managing project statisticians required.
Please refer to Job code TV2286 when responding to this ad.
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