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Clinical SAS Programmer

Employer
Aerotek
Location
Rockville, MD
Closing date
Oct 19, 2019

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Clinical SAS Programmer Job Summary: Client is seeking an individual with extensive knowledge and experience in applying CDISC standards (SDTM, CDASH, ADaM, SEND, Define-XML) and advanced SAS programming skills, to support or lead one or more Phase 1- 4 clinical trials, across a variety of therapeutic areas. You will report to the Director of Data Services and Development, Clinical Trials Practice. Job Responsibilities: Provide SAS programming and validation support for clinical study reports (CSRs) and other types of statistical reports (for FDA and other health related agencies/organizations). Produce and validate SDTM and ADaM data sets/analysis files, and tables, listings, and figures (TLFs). Produce and validate Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE). Create SAS data sets from various database management systems (eg, EDC) and PC file formats. Assist clinical statisticians in the development and review of statistical analysis plans (SAPs) and SAS programming specifications. Assist data management in development and SAS programming of edit specifications. Follow CTP SOPs to ensure compliance with requirements, client (sponsor) requirements and FDA and ICH regulatory guidelines. Determine when SAS software upgrades and Hot Fixes are required for the Clinical SAS Programming Team and ensure SAS software is installed, maintained, and documented in a regulatory compliant manner. Develop SAS macro libraries to standardize routine analysis or implement new methods. Manage the Clinical SAS Programming Team, maintain standards for Clinical SAS programming activities, and guide/coach the Clinical SAS Programmers. Basic Qualifications: Bachelor's degree in Statistics, Computer Science, Mathematics or related field. 5+ years relevant experience supporting clinical trials in the Pharmaceutical, Biotechnology or CRO industry that includes SAS programming and the use of FDA Data Standards for Electronic Submissions. Candidates need to have a strong understanding of FDA and ICH regulatory guidelines, clinical data, CDISC standards, and the software development lifecycle (SDLC). Candidates must also possess excellent written and oral communication skills and be willing to share their knowledge and skills with more junior programming staff.

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