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Job Title: Senior Biostatistician III
Job Location: MA: Boston
Pay Rate: Open
Job Length: full time
Start Date: 2008-01-25
Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856
Description: The Senior Biostatistician III will work with biometric staff, medical director, and clinical monitors on clinical development plans; the design and conduct of clinical studies; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA. As part of a development assessment team, collaborate in the preparation and review of the clinical development plan. For assigned clinical development projects, provide statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements. Review all project protocols, author protocol statistical analysis sections, and generate study randomization. Review case report forms to ensure that protocol objectives are met and project standards are maintained. Develop study analysis plans as a team member and lead this effort for selected studies. Develop statistical programs as necessary to perform analyses and prepare data displays. Author results sections of the clinical study report. Supply statistical input for BLA submissions and in response to FDA questions. Provide support for publication of clinical trial results. Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings. Lead the analysis and reporting of a clinical trial program, including ISS and ISE. Provide leadership, quality review, and mentoring to less experienced biostatisticians which may include coordinating the work of a team of biostatisticians and/or programmers. Understand and have the ability to use advanced statistical methods (e.g., application of logistic regression, repeated measures analysis of variance, survival analysis). Ensure all work is processed on time to appropriate quality levels. Coordinate and ensure the accuracy of clinical trial randomizations. Perform protocol development/sample size calculation and protocol/CRF review. Prepare statistical analysis plans with fully documented table, listing, and figure shells. Prepare documentation/specification to aid SAS code produced for analysis programs. Develop SOPs pertaining to Biostatistics and SAS programming, consistent with FDA and ICH regulations and guidelines. Participate in and/or lead process/quality improvement initiatives. Requirements: knowledge of SAS programming, good analytical skills and the ability to communicate technical concepts clearly and concisely. A MS with at least 7 years or a PhD with 5 years of experience in the pharmaceutical industry is necessary.
Please refer to Job code TV5261 when responding to this ad.
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