Network and Systems Professionals Association (NaSPA)
The incumbent will be working with a cross‑functional team as the in-house unblinded biostatistician for interim analyses or regulatory submissions, and as project biostatistician responsible for statistical activities at compound level or study level, reporting to Head of Biometrics or designee. The ideal candidate is a good communicator, high-energy, self-motivated, and forward‑thinking. Experience working in rare disease is desirable, but not required.
- Serve as the in-house unblinded biostatistician for interim analyses or regulatory submissions, working with unblinded statistical programmer(s) to oversee the statistical deliverables, interpret the statistical analyses for senior leaders, and contribute to regulatory submissions
- May also serve as the project biostatistician responsible for statistical activities at compound level or study level
- Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
- Conduct statistical modeling to enable robust statistical designs or analyses 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 the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and 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
- 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
- Be accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
- Address statistical questions/comments from 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 or lead standardization and process improvement efforts for Biostatistics function and contribute to cross-functional process improvement efforts
- Represent Sarepta regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
Education and Skills Requirements:
- Ph.D. in statistics or related discipline with nine years of experience in the pharmaceutical or biotech industry
- Demonstrated ability and experience in the design, analysis and reporting of clinical trials
- Experience in NDAs, MAAs, J-NDA, or other regulatory submissions desirable
- In-depth knowledge of statistical methods for clinical trials, including Bayesian approaches
- Knowledge of FDA, EMA and ICH regulations and guidelines
- Proficient in statistical programming (SAS and/or R)
- Experience with trial design software (e.g., EAST)
- Ability to concurrently lead statistical efforts for multiple studies
- Understanding of data standards, including SDTM and ADaM
- Adept at overseeing statistical services provided by CRO's and/or contractors
- Ability to work independently and act with initiative to address issues
- Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally.
- 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 ID: 51559707
Cambridge, Massachusetts, United States
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.
Sr. Manager, Drug Product Process Development & Manufacturing
Burlington, Massachusetts, United States
Posting ID: 564709505Posted: 2020-08-08