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 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.
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
#LI-Remote
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.
R-02425