Overview: Under general supervision, provide a wide range of advanced statistical expertise, guidance, and support to researchers, scientists, and managers engaged in clinical research studies within the physical, life, and/or applied sciences. Participate in the Bayesian trial design and analysis, sample size estimation, development of Primary and multiple Secondary endpoints, patient reported outcomes, Post-market Statistical Issues, and reporting of clinical trials/studies, and respond to a broad range of statistical issues and deficiencies arising in a variety of settings including form submissions made to the regulatory agencies (FDA, Notified Body, Competent Authority, etc.). Supervise Statistical methodology support, data analysis, interact with the CRO's, as necessary to meet objectives of the trial and submission and the nature of the project.
Requirements: Master's Degree in Biostatistics with 5-7 years experience, or Doctorate in Biostatistics with 3-5 years experience directly related to the duties and responsibilities specified. 1-2 years experience with the FDA regulated clinical trials (e.g., class III Medical Devices) including experience in performing data analysis for FDA submission (e.g., PMA) is essential. Familizaration/exposure to 21 CFR part 11 requirements and compliance is desired.
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