Associate Director, Biostatistics

Sarepta Inc; Time; Hybrid; NOK 1,894,000 - 2,368,000; Full time

Job summary

Sarepta Therapeutics is seeking a project biostatistician to lead statistical activities for one or more programs, contributing to trial design, analysis, and regulatory submissions. This role emphasizes collaboration with CROs and internal teams to advance precision genetic medicine and impactful therapies for patients.

The position requires a Ph.D. in Statistics or related field, strong communication, and experience in clinical trials within pharma/biotech.

Qualifications

• Ph.D. in Statistics or related discipline is required.
• At least five years in pharma/biotech for Associate Director; at least three years for Sr. Manager.
• Experience designing, analyzing and reporting clinical trials.

Responsibilities

• Coordinate planning and execution of statistical deliverables with internal and external teams.
• Develop statistical models for robust designs and address issues in studies.
• Contribute to protocol development and review sections with statistical input.

Skills

Clinical trial design

Statistical analysis

Regulatory submissions

Communication skills

Cross-functional collaboration

Education

PhD in Statistics or related discipline

Tools

SAS

R

EAST

Job description

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.

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 programs. It is an excellent opportunity to work at the forefront of precision genetic 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.

The Opportunity to Make a Difference

• 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

More About You

• Ph.D. in Statistics or related discipline
• At least five years of experience in the pharmaceutical or biotech industry for Associate Director; at least three years of experience in the pharmaceutical or biotech industry for Sr. Manager level
• Demonstrated ability and experience in the design, analysis and reporting of clinical trials
• Experience in NDAs, MAAs, or other regulatory submissions desirable, but not required
• In-depth knowledge of statistical methods for clinical trials
• Working knowledge of FDA, EMA and ICH regulations and guidelines
• Proficient in statistical programming in SAS and R
• Proficient in statistical design software such as EAST
• Ability to concurrently work on multiple studies
• Understanding of data standards, including SDTM and ADaM
• Ability to oversee statistical services provided by CRO’s and/or contractors
• Ability to collaborate effectively with colleagues from other functions
• Excellent written and oral communication skills

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.

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 CHF164,800 - CHF206,000 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.