Clinical SAS Programmer
MD - Rockville
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.
Westat is experiencing rapid commercial growth in the area of FDA-regulated clinical research and there is a need to hire a Senior Clinical SAS Programmer to join our Clinical Trials Practice (CTP). We are 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 Acting Data Services and Development lead, Clinical Trials Practice.
â€¢ 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).
â€¢ Produce and validate SDTM and ADaM data sets/analysis files, and tables, listings, and figures (TLFs).
â€¢ Produce and validate Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE).
â€¢ Create SAS data sets from various database management systems (e.g., EDC) and PC file formats.
â€¢ Assist clinical statisticians in the development and review of statistical analysis plans (SAPs) and SAS programming specifications.
â€¢ Assist data management in development and SAS programming of edit specifications.
â€¢ Follow CTP SOPs to ensure compliance with Westat requirements, client (sponsor) requirements and FDA and ICH regulatory guidelines.
â€¢ Develop SAS macro libraries to standardize routine analysis or implement new methods.
â€¢ Manage the Clinical SAS Programming Team, maintain standards for Clinical SAS programming activities, and guide/coach the Clinical SAS Programmers.
â€¢ A bachelor's degree in Statistics, Computer Science, Mathematics or related field.
â€¢ At least 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.
â€¢ SAS Certified Clinical Trials Programmer Using SAS 9.
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.
Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits.
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the position, based on the specific position which may include, for example, identity verification, employment history, or criminal records history.
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity, or any other protected status under applicable law.
Research - Clinical Trials