Associate Director, Biostatistics

Sarepta Therapeutics•Cambridge, MA

11h•Hybrid

About The Position

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role 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 gene therapies, 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. The Opportunity to Make a Difference Support departmental initiatives within the biometrics team, including the development and implementation of SOPs, optimization of working processes, centralized data standardization, and analytical projects. Works collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables Conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles Authors or reviews statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses More about You Designs and specifies randomization schedules; reviews and approves test randomization lists Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents Reviews analysis dataset specifications Performs QC/QA of statistical deliverables including validation of key analysis results Performs ad hoc and exploratory statistical analyses as needed Contributes to clinical study reports, including authoring of statistical methods and interpretation of the study results Be responsible for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs Supports and contributes to the preparation of publications, including manuscripts, posters and oral presentations Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid Blank This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $173,200 - $216,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. 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. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Nice To Haves

Experience working in rare disease is desirable, but not required.

Responsibilities

Support departmental initiatives within the biometrics team, including the development and implementation of SOPs, optimization of working processes, centralized data standardization, and analytical projects.
Works collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
Conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
Authors or reviews statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings
Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
Designs and specifies randomization schedules; reviews and approves test randomization lists
Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
Reviews analysis dataset specifications
Performs QC/QA of statistical deliverables including validation of key analysis results
Performs ad hoc and exploratory statistical analyses as needed
Contributes to clinical study reports, including authoring of statistical methods and interpretation of the study results
Be responsible for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs
Supports and contributes to the preparation of publications, including manuscripts, posters and oral presentations
Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts