Job Category: Clinical & Statistics

Senior Director, Biostatistics (MGM)

Job Location: Cambridge, MA.

RESPONSIBILITIES:
Serve as the lead statistician across clinical development. Ensure that clinical development programs meet scientific, regulatory, and quality requirements programs. Perform management of in-house and/or outsourced biostatisticians/programmers, and mentor these team members. Apply innovative statistical approaches to study design, analysis and data exploration methodologies. Plan and track study level activities within programs, including resources; ensure CRO timelines and objectives are met. Help establish and maintain data standards, within and across programs.

REQUIREMENTS:
PhD in Biostatistics or related discipline with 12+ years of biopharmaceutical experience. Prior experience as a program statistician (7+ years). Prior in-house statistician management (4+ years). Experience with Regulatory agencies. Experience with Bayesian methods preferred.

Please contact Manja Molan at mmolan@clarkdavis.com

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