Primary Responsibilities Include:

• 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

Desired Education and Skills:

• 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

This position is remote. However, 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.

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.