Clinical SAS Programmer

Employer
Westat
Location
Rockville, VA
Posted
May 29, 2021
Closes
Jun 29, 2021
Industry
Research
Hours
Full Time
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.

Job Summary: 
Westat is experiencing rapid commercial growth in the area of FDA-regulated clinical research and there is a need to hire a 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 Design and Analysis Programming Lead within the 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, figures, and listings (TFLs).
•    Produce and validate Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE).
•    Create SAS data sets from various database management systems (e.g., 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 Westat requirements, client (sponsor) requirements and FDA and ICH regulatory guidelines.
•    Develop SAS macro libraries to standardize routine analysis or implement new methods.

Basic Qualifications:
•    A Bachelor's degree in Clinical Health Science, Computer Science, Statistics, Mathematics or related field. 
•    At least 5 years relevant experience supporting clinical trials in the Pharmaceutical, Biotechnology or CRO industry that includes SAS programming 
•    Use of FDA Data Standards for Electronic Submissions.

Preferred Qualifications:
•    A Master's degree in Business Administration, Computer Science, Statistics, Mathematics or related field. 
•    SAS Certified Clinical Trials Programmer Using SAS 9.
•    Candidates need to have a strong understanding of FDA and ICH regulatory guidelines, clinical data, and CDISC standards

Qualified candidates must have excellent communication skills. In addition, candidates must possess organizational and time management skills, the ability to exercise independent judgement, work independently and collaboratively in teams, and manage multiple tasks simultaneously.

Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:
  • Employee Stock Ownership Plan
  • 401(k) Retirement Plan
  • Paid Parental Leave
  • Vacation Leave
  • Sick Leave
  • Holiday Leave
  • Professional Development
  • Health Advocate
  • Employee Assistance Program
  • Travel Accident Insurance
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • Life and AD&D Insurance
  • Critical Illness Insurance
  • Supplemental Life Insurance
  • Flexible Spending Account
  • Health Savings Account

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 expression, or any other protected status under applicable law.