Association for Clinical and Translational Science

Senior Manager, Biostatistics

Sarepta Therapeutics
Cambridge, Massachusetts, United States
6 days ago

Description

The incumbent will be working with a cross‑functional team as the project biostatistician responsible for statistical activities at study level or compound level, reporting to a Biostatistics Lead for a platform/asset. The ideal candidate is a good communicator, high-energy, self-motivated, and forward‑thinking. Experience working in rare disease is desirable, but not required.

Primary responsibilities:

  • Serve as a biostatistics expert or point of contact for assigned clinical studies or compound-level activities
  • Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
  • Conduct statistical modeling and simulations to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
  • Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
  • Author or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listings
  • Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
  • Design and specify randomization schedules; review and approve test randomization lists
  • Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
  • Review analysis dataset specifications
  • Validate the results of key statistical deliverables
  • Perform ad hoc and exploratory statistical analyses as needed
  • Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results
  • Contribute to statistical activities in support of IND/NDA/MAA or other regulatory submissions
  • Provide statistical input to communications with the FDA and other regulatory agencies, and review and address comments by IRB/ECs
  • Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations
  • Contribute to standardization and process improvement efforts for Biostatistics function and contribute to cross-functional process improvement efforts

Education and Skills Requirements: 

  • Ph.D. in Statistics or related discipline
  • At least three years of experience in the pharmaceutical or biotech industry for Sr. Manager level, and at least five years of experience in the pharmaceutical or biotech industry for Associate Director
  • Working knowledge in the design, analysis and reporting of clinical trials through phase 3
  • Experience designing and conducting adaptive trials is a plus, but not required
  • Working knowledge of FDA, EMA and ICH regulations and guidelines
  • Proficient in statistical programming including SAS and other statistical software such as R and EAST
  • Ability to concurrently work on multiple studies
  • Knowledge of CDISC, including SDTM and ADaM
  • Excellent written and oral communication skills

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.



Job Information

  • Job ID: 57762499
  • Location:
    Cambridge, Massachusetts, United States
  • Position Title: Senior Manager, Biostatistics
  • Company Name: Sarepta Therapeutics
  • Job Function: Biostatistics

Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.

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