Senior Director, Biostatistics 8/21/2020
JOB DESCRIPTIONAPPLY This individual will be the Biometrics Team Lead for limb-girdle muscular dystrophy (LGMD) for which Sarepta is developing multiple gene therapies targeting different subtypes. Reporting to the Head of Biometrics, this individual will work with cross-functional teams to advance transformative precision genetic medicines for people with LGMD. The ideal candidate must be able to lead a Biometrics team comprising biostatisticians and statistical programmers, and excel as a hands-on innovative biostatistician. He/she will be a strategic thinker, a good communicator, high-energy, self-motivated, and forward thinking. Experience working in rare disease or gene therapy is desirable, but not required.
PRIMARY RESPONSIBILITIES INCLUDE:
* Lead the Biometrics Team comprising of biostatisticians and statistical programmers for LGMD and accountable for all Biometrics activities across all clinical programs in LGMD
* Provide statistical strategies and expertise for clinical development, regulatory submission and patient access data generation for the accountable gene therapy programs
* Lead the planning and execution of statistical deliverables at platform level, program level and study level through working with internal and external (e.g., FSP or CRO) biostatisticians and statistical programmers
* Conduct or collaborate on 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 oversee 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
* Plan and execute the validation 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 statistical activities in support of IND/NDA/MAA or other regulatory submissions
* Address statistical questions/comments from FDA, EMA, 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
* Manage direct reports and/or contractors in Biostatistics, with responsibility of recruiting, mentoring and developing of direct report(s), and performance evaluation.
EDUCATION AND SKILLS REQUIREMENTS:
* Ph.D. in statistics or related discipline with at least ten years of experience in the pharmaceutical or biotech industry
* Experience of providing statistical leadership for clinical development programs
* Demonstrated ability and experience in the design, analysis and reporting of clinical trials
* Experience leading NDAs, MAAs or other regulatory submissions
* In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
* Knowledge of FDA, EMA and ICH regulations and guidelines
* Knowledge of immunology and/or gene therapy is desirable, but not required
* Proficient in statistical programming (SAS and R)
* Experience with trial design software (e.g., EAST)
* Ability to concurrently lead statistical efforts for multiple projects
* Understanding of data standards, including SDTM and ADaM
* Adept at overseeing statistical services provided by CRO s
* Ability to concurrently lead or coordinate statistical efforts for multiple projects
* Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally
* Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: patients first, action, unconventional thinking, talent, and integrity
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.