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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 RNA 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:
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Works collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables.
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Conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs.
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Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles.
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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.
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Reviews case report form (CRF) designs to ensure data collection meets the requirements of statistical analyses.
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Designs and specifies randomization schedules; reviews and approves test randomization lists.
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Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents.
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Reviews analysis dataset specifications
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Performs QC/QA of statistical deliverables including validation of key analysis results.
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Performs ad hoc and exploratory statistical analyses as needed.
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Contributes to clinical study reports, including authoring of statistical methods and interpretation of the study results.
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Be responsible for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions.
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Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs
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Supports and contributes to the preparation of publications, including manuscripts, posters and oral presentations.
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Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts.
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Represents Sarepta regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners.
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Serves as a mentor to junior team members.
Desired Education and Skills
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Five years (Ph.D.) or eight years (Master) or more experience in the pharmaceutical or biotech industry
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Demonstrated ability and experience in the design, analysis and reporting of clinical trials.
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Demonstrated ability and experience in the design, analysis and reporting of clinical trials.
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Experience in NDAs, MAAs, or other regulatory submissions desirable, but not required.
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In-depth knowledge of statistical methods for clinical trials
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Working knowledge of FDA, EMA and ICH regulations and guidelines
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Proficient in statistical programming in SAS and R
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Proficient in statistical design software such as EAST
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Ability to concurrently work on multiple studies.
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Understanding of data standards, including SDTM and ADaM
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Ability to oversee statistical services provided by CRO’s and/or contractors.
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Ability to collaborate effectively with colleagues from other functions.
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Excellent written and oral communication
#LI-TD1
#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.
The targeted salary range for this position is $156,000 - $195,000 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.
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