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Sr. Director/Director, Biostatistics, Medical Affairs/RWE

Company: Sarepta Therapeutics
Location: Cambridge
Posted on: June 26, 2019

Job Description:

Reporting to the Head of Biometrics, this individual will provide statistical expertise and leadership as the Biometrics Lead for all real-world evidence (RWE) activities across the company. He/she will work closely with Global Medical Affairs and other stakeholders to develop and implement RWE strategies and RWE study protocols, and will be responsible for statistical deliverables by working with Statistical Programming and other functions. The ideal candidate is a good communicator, high-energy, self-motivated, and forward thinking.

Primary responsibilities:

* Provide statistical expertise and leadership as the Biometrics Lead for all RWE activities across the company

* Work collaboratively with Global Medical Affairs and other stakeholders to develop and implement RWE strategies to support regulatory, publication and patient access

* Provide statistical guidance/input and author/review Statistics section of RWE study protocols, including those for post-marketing safety studies, payer studies, natural history studies, and comparative effectiveness assessment studies

* Author or oversee the development of statistical analysis plans for RWE studies, and oversee the development of shells for tables, figures and listings

* Work with internal or external (CRO) Statistical Programming team for the execution of statistical deliverables for all RWE studies

* Conduct statistical modeling and simulation to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in RWE studies

* Review case report form (CRF) or other data collection designs to ensure data collection meet the requirements of statistical analyses

* Design and specify randomization schedules, and review and approve test randomization lists, as needed

* Validate the results of key statistical deliverables

* Perform ad hoc and exploratory statistical analyses as needed

* Contribute to RWE study interim and final reports, including authoring/reviewing sections on statistical methods and interpretation of the study results

* Contribute to publications such as manuscripts, conference posters and oral presentations based on RWE studies, including authoring/reviewing of sections for statistical analyses

* Address statistical questions/comments from FDA and other regulatory agencies for RWE studies

* Represent Sarepta regarding statistical issues on RWE studies in meetings with external parties including regulatory agencies and corporate partners

Education and Skills Requirements:

* Ph.D. in statistics or related discipline with at least nine years of experience in the pharmaceutical or biotech industry

* Demonstrated ability and experience in the design, analysis and reporting of RWE studies, including registries, payer studies, natural history studies, and comparative effectiveness assessment studies, especially in rare diseases

* In-depth knowledge of statistical methods for RWE studies, including both frequentist and Bayesian approaches

* Knowledge of FDA, EMA and ICH regulations and guidelines

* Proficient in statistical programming (SAS is required and R is a plus)

* Ability to concurrently lead statistical efforts for multiple projects

* Adept at overseeing statistical services provided by CRO s and/or contractors as needed

* Understanding of data standards, including SDTM and ADaM

* 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.

Keywords: Sarepta Therapeutics, Methuen , Sr. Director/Director, Biostatistics, Medical Affairs/RWE, Executive , Cambridge, Massachusetts

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