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Job Title: Sr. Manager, Biostatistics
Description:
Provide statistical input to the development plan, protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Summary of Clinical Safety (SCS), Summary of Clinical Efficacy (SCE), and other sections of NDA/BLA. Advise on technical issues associated with the design and analysis of clinical trials. Contribute to Annual Reports (AR) and Investigator's Brochure (IB). Provide support on statistical aspects of all FDA interactions, including FDA meetings, responses to FDA questions, and Advisory Committee Meetings. Work with team in defining strategic approaches to clinical trials and in meeting operational requirements of product development plans. Work closely with Biostatistics management to ensure a coordinated approach to biostatistics objectives. Apply novel statistical procedures to projects as appropriate; interact with and manage CROs on deliverables.
Qualifications:
Comprehensive knowledge of theoretical and applied statistics, and regulatory guidelines regarding clinical trial analysis and reporting; NDA/BLA experience desirable. Effectively collaborate, communicate, and influence throughout all levels of organization. Demonstrated ability to work in a team environment and handle multiple projects. Strong leadership abilities and demonstrated ability to effectively manage and interact with CROs. Oncology experience preferred; experience in SAS and/or S+ programming required.
MS or PhD in statistics, biostatistics or other related scientific area; PhD in statistics/biostatistics preferred. Minimum 4-8 years of experience in the biotechnology or pharmaceutical industry.
Compensation:
Commensurate with experience
Date Posted: 06/03/2008
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
