Associate Director, Biostatistics

Company: Sarepta Therapeutics
Location: Somerville
Posted on: January 14, 2021

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 gene therapy programs. It is an excellent opportunity to work at the forefront of precision 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 activitiesWork collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverablesConduct statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programsContribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principlesAuthor or review the development of 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 listingsReview case report form (CRF) designs to ensure data collection meet the requirements of statistical analysesDesign and specify randomization schedules; review and approve test randomization listsProvide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documentsPerform QC/QA of statistical deliverables including validation of key analysis resultsPerform ad hoc and exploratory statistical analyses as neededContribute to clinical study reports, including authoring of statistical methods and interpretation of the study resultsBe accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissionsAddress statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECsSupport and contribute to the preparation of publications, including manuscripts, posters and oral presentationsContribute or lead standardization and process improvement efforts for Biometrics and contribute to cross-functional process improvement effortsRepresent Sarepta regarding statistical issues in meetings with external parties including regulatory agencies and corporate partnersEducation and Skills Requirements: Ph.D. in statistics or related disciplineAt least five years of experience in the pharmaceutical or biotech industryDemonstrated ability and experience in the design, analysis and reporting of clinical trialsExperience in NDAs, MAAs, J-NDA, or other regulatory submissions desirable, but not requiredIn-depth knowledge of statistical methods for clinical trials, including Bayesian approachesKnowledge of FDA, EMA and ICH regulations and guidelinesProficient in statistical programming (SAS and R)Experience with trial design software (e.g., EAST)Ability to concurrently take on multiple activitiesUnderstanding of data standards, including SDTM and ADaMAdept at overseeing statistical services provided by CRO---s and/or contractorsAbility to work independently and act with initiative to address issuesAbility to collaborate effectively with colleagues from all functionsExcellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner.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.Full time

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