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Associate Director Statistics

Cambridge, Massachusetts


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Associate Director Statistics

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Job ID R0022748 Date posted 09/21/2020 Location Cambridge, Massachusetts

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Job Description

Provide statistical oversight for multiple marketed products, while collaborating with clinical science, drug safety, regulatory, and other R&D functions in the strategic management of marketed products.

Candidate expectations include the following:

  • Independently manage the statistical aspects of clinical studies including: study protocol design, SAP, management of statistical deliverable, writing of study report.
  • Provide oversight of statistical work performed by contract clinical research organizations.
  • Experience leading NDA/SNDA (or similar) submission including product labeling.
  • Experience interacting with and responding to regulatory agencies (e.g. FDA).
  • Proficiency with interacting with clinical scientist for data interpretation and product strategy.
  • A strong understanding of the overall drug development process and flexibility to work on multiple different projects simultaneously.
  • Good analytical and problem solving skills.
  • Proficient in statistical programming with SAS.
  • Knowledge of FDA, EMA and ICH regulations and guidelines.
  • Masters degree in Statistics with 8+ years experience or PhD degree in Statistics with 5+ years experience.


Cambridge, MA

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Full time

Job ID R0022748

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