Reporting to Statistical Programming Lead for Statistical Innovation, the incumbent will be responsible for providing hands-on programming support and technical guidance on statistical innovation activities. This individual will partner with other members of the Statistical Innovation team in the design, development and execution of innovation initiatives to accelerate clinical development.
* Partner with biostatistician(s) of the Statistical Innovation team to deliver programming solutions to enable innovative statistical designs and analyses to accelerate clinical development programs * Provide simulation support to evaluate innovative statistical methodologies as applicable to clinical development * Monitor advances in statistical computing tools and computation methodology through conference participation and interactions with internal/external experts on statistical innovation * Conduct on-demand meta-analyses across clinical development programs utilizing clinical study data and potentially external control data through custom coding * Provide programming support for ad-hoc and exploratory analyses * Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications) * Manage project timelines and schedules of specific phases of projects * Provide oversight of statistical programming activities of vendors as needed * Participate in development of Statistical Programming deliverables processes and standards, as appropriate. * Review or author statistical programming related Standard Operating Procedures or Working Instructions
* MS in Statistics, Computer Science or a related field with at least 5 years (or BS in Statistics, Computer Science or a related field with at least 8 years) of SAS/R programming experience in the pharmaceutical or biotech industry * Experience in project management of statistical programming activities * Proficiency in multiple statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc. * Experience in Shiny app development and deployment * Experience in high performance computing * Experience in UNIX/Linux computing environment * Experience in providing statistical programming support to early and late phase clinical trials; regulatory submission experience is a plus but not required * Excellent skills in SAS or R programming and statistical reporting * Working knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements * Familiarity with FDA and ICH regulations and guidelines * Excellent problem-solving skills * Excellent written and verbal communication skills and organizational and documentation skills * Ability to work on a multidisciplinary team * Ability to prioritize and multi-task effectively * Demonstrate positive attitude and the ability to work well with others
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.
About Sarepta Therapeutics
Sarepta Therapeutics is a biopharmaceutical company focused on developing innovative RNA-targeted therapeutics.