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Category: Research and Development - Biostatistics and Data Management More information about this job: Overview:
The Senior Biostatistician/Associate Director, Biostatistics provides expert biostatistics support for the planning, design, conduct, analysis and reporting of clinical studies, as well as general statistical support for R&D and other departments. Principal responsibilities include the statistical design of Phase I - IV clinical studies (specification of study hypotheses, sample size estimation and power calculations), the statistical delineation of study endpoints, writing statistical sections of clinical trial protocols and developing, reviewing and finalizing statistical analysis plans (SAP) to be used for the programming, analysis and reporting of study data. The Senior Biostatistician/Associate Director will also develop SAPs in support of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) and perform detailed statistical review of all statistical deliverables, including analysis tables, listings and figures (TLFs). In addition, the Senior Biostatistician/Associate Director will work closely with statistical programmers and external vendors to develop and implement specifications for the programming of statistical outputs and analyses. Responsibilities / Qualifications:
The position requires a PhD Biostatistics or Applied Statistics minimum of 3-5 years of biostatistics experience in a clinical trials environment. Strong interpersonal, teamwork, and organizational skills are essential. Infrequent travel required for meetings with service providers, partners and the FDA will be required. Apply for this job:
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