Principal Statistical Programmer at Sarepta Therapeutics in Cambridge, Massachusetts

Job Description:

Reporting into Statistical Programming Department, the individual will be responsible for providing hands-on 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. This individual will participate in departmental and cross functional technology development and process improvement initiatives.

Responsibilities:

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).


• Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.


• Create and validate tables, figures and listings (TFLs) 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.


• Lead one or multiple studies, and create submission-ready electronic data packages.


• Provide input in the user requirements specification, system design specifications, validation plan, and installation/operational/performance qualification for statistical programming systems.


• Create automated, standard programming; SAS macros and stored procedures as required.


• Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.


• Review or author SDTM and ADaM datasets specifications for datasets programming.


• Provides programming support for adhoc analysis.


• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).


• Manages project timelines and schedules of specific phases of projects with internal personnel and external vendors.


• Provide oversight of statistical programming activities of vendors


• Review eCTD documents to support regulatory submission package


• Review or author statistical programming related Standard Operating Procedures or Working Instructions.


• Train or mentor junior statistical programming staff

Qualifications

• MS in statistics, computer science or a related field with at least 8 years (or BS in statistics, computer science or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry


• Prior experience of independently leading projects for regulatory submission for 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).


• Proficient in SAS programming.


• In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.


• Experience in developing programming specifications, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format.


• Experience with FDA and ICH regulations and guidelines.


• Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.


• Demonstrate excellent leadership 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.


• 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.