Sr. Director, Biostatistics

Posted on Jan 22, 2019 by Sarepta Therapeutics

Not Specified, PR
Research & Development
Immediate Start
Annual Salary
Full-Time
Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit us at ., 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 . Sarepta Therapeutics Sr. Director, Biostatistics Apply Now * Print * Save * Share Description The Company: Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit us at . The Position: The incumbent will be working with a cross-functional team as the Biostatistics Lead for multiple gene therapy clinical development programs, and will be reporting to the Head of Biometrics. The ideal candidate is a strategic thinker, good communicator, high-energy, self-motivated, and forward-thinking. Experience working in rare disease or gene therapy is desirable, but not required. The level of the position will commensurate with experience. Primary responsibilities: * Provide statistical strategies for clinical development, regulatory submission and patient access data generation for assigned 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 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 * 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 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 1 or more direct reports and/or contractors, 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 * Proficient in statistical programming (SAS is required and R is a plus) * 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 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. * Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion 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 * Location: Cambridge, Massachusetts, 02142, United States * Job ID: * Posted: December 21, 2018 * Position Title: Sr. Director, Biostatistics * Company Name: Sarepta Therapeutics * Job Function: Biostatistics * Entry Level: No About Sarepta Therapeutics 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 . More Jobs from Sarepta Therapeutics Jobs You May Like Associate Director/Director, US Medical Affairs Sarepta Therapeutics Cambridge, United States Associate Director, Statistical Programming Sarepta Therapeutics Cambridge, United States Sr. Manager/Associate Director, Biostatistics Sarepta Therapeutics Cambridge, United States Manager, Compliance Operations Sarepta Therapeutics Cambridge, United States The incumbent will be working with a cross-functional team as the Biostatistics Lead for multiple gene therapy clinical development programs, and will be reporting to the Head of Biometrics. The ideal candidate is a strategic thinker, good communicator, high-energy, self-motivated, and forward-thinking. Experience working in rare disease or gene therapy is desirable, but not required. The level of the position will commensurate with experience., * 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 * Proficient in statistical programming (SAS is required and R is a plus) * 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 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. * Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package.

Reference: 615425753

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