Reporting into Statistical Programming Department, the incumbent will be responsible for providing hands-on programming support and technical guidance on clinical project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies.
* Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical project(s).Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.
* Create and validate tables, figures and listings (TFLs) working closely with cross-functional teams in a timely and high quality fashion, consistently meeting objectives of the study, and regulatory requirements.
* Provide input in the design and development of case report forms and clinical databases.
* Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
* Create and review aCRF, SDTM and ADaM datasets specifications for datasets programming.
* Draft and review Data Transfer specification with vendors as necessary.
* Create and review eCTD documents to support regulatory submission package.
* Provide programming support for adhoc analysis.
* 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 with internal personnel and external vendors.
* Provide oversight of statistical programming activities of vendors.
* Participate in development of Statistical Programming deliverables processes and standards, as appropriate.
* Review or author statistical programming related Standard Operating Procedures or Working Instructions.
* Train or mentor junior statistical programming staffs.
* 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 programming experience in the pharmaceutical or biotech industry.
* Experience in project management of statistical programming activities.
* Proven ability to manage CRO relationships and oversee programmed deliverables.
* Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA).
* Excellent skills in SAS programming and statistical reporting.
* In-depth 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 that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
* 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.