Senior Manager, Biostatistics at Sarepta Therapeutics in Cambridge, Massachusetts

Posted in Other 12 days ago.





Job Description:

The person in this position will be working with a cross functional team as the project biostatistician responsible for statistical activities at the compound level or study level for one or more RNA therapy programs. It is an excellent opportunity to work at the forefront of precision genetic medicine, making an impact to the development of transformative therapies that may change the lives of patients. 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 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 the development of statistical analysis plans (SAPs) 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 (TLF)

  • 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

  • Perform QC/QA of statistical deliverables including validation of key analysis results

  • Perform ad-hoc and exploratory statistical analyses as needed

  • Contribute to clinical study reports (CSRs), 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 Biometrics and contribute to cross-functional process improvement efforts

  • Represent Sarepta regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners

Qualifications:


  • Ph.D. in statistics or related discipline with at least 3 plus years of experience in the pharmaceutical or biotech industry

  • Proven knowledge and expertise in statistics / clinical trials methodology and applications to clinical development

  • Strong analytical and problem-solving skills

  • Knowledge in FDA/CHMP/ICH guidelines

  • Experience with BLAs, MAAs and other regulatory submissions is a plus

  • Adept at overseeing statistical services provided by CRO's and/or contractors

  • Knowledge of CDISC standards, including SDTM and ADaM

  • Proficient and working knowledge with statistical software including SAS, R, EAST, among others

  • Excellent communication and presentation skills, including the ability to effectively communicate statistical concepts in a clear and concise manner to non-statistics audience

  • Good organizational skills, enough to multi-task in a fast-paced environment with changing priorities

  • Team player, with ability to collaborate successfully across functions

  • Knowledge and working experience in innovative trial designs such as adaptive design, Bayesian historical data borrowing, platform trials/master protocol, using of surrogate endpoint desirable

  • Knowledge and experience in adopting ICH E9 (R1) Estimands addendum in clinical development is a plus

  • Hands-on Bayesian computation, complex trial simulations and advanced R programming skills is a plus

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.