SAS Programmer

Clearance Level
None
Category
Programming
Location
Remote, Working from North Carolina
Key Skills For Success

Datasets

SAS

Statistical Programming

REQ#: RQ167632
Public Trust: NACI (T1)
Requisition Type: Regular
Your Impact

Own your opportunity to work alongside federal civilian agencies. Make an impact by providing services that help the government ensure the well being of U.S. citizens.

Job Description
GDIT's Military Health team is hiring a SAS programmer to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.HOW YOU WILL MAKE AN IMPACT:
  • Develop CDISC compliant statistical programming specifications (clinical data) and other statistical programs used to produce the tables, listings, and figures for studies, all versions used for the Data Monitoring Committee, safety surveillance plans, FDA annual report, interim analyses (if applicable), and any ad hoc analyses.
  • Produce data-populated tables, listing, and figures for studies, the Data Monitoring Committee, safety surveillance plans, FDA annual reports, interim analyses (if applicable), and any ad hoc analyses.
  • Develop all versions of CDISC validation plans, and write and revise as necessary CDISC validation reports summarizing results from CDISC validation and including all output from the Pinnacle 21 Open CDISC validation software (or latest version of Open CDISC.
  • Develop and revise as required statistical programming specifications used to create CDISC-compliant datasets, SDTM, Analysis Data Model (ADaM) datasets, and Standard for Exchange of Nonclinical Data (SEND) (for non-clinical data); Develop define.xml and define.pdf to include coding conventions used in the statistical programs (all versions) for CDISC datasets; Develop SEND datasets conforming to CDISC standards (non-clinical data); Develop SDTM datasets conforming to CDISC standards; Develop ADaM datasets conforming to CDISC standards as required.
  • Develop and update as required CDISC reviewer’s guides.
  • Provide written responses to sponsor and FDA requests/queries regarding statistical products
WHAT YOU’LL NEED TO SUCCEED:
  • Bachelor’s Degree in Computer Science, Statistics or a related discipline, or the equivalent combination of education, professional training, or work experience.
  • 5 years of related SAS programming experience.
  • Knowledge of CDISC standards
  • Excellent written and oral communication skills.
  • Must be U.S. citizen and able to obtain a T1.
WHAT GDIT CAN OFFER YOU: 
  • Challenging work that makes a real impact on the world around you  
  • Internal mobility team dedicated to helping you own your career 
  • 401K with company match 
  • Diverse, highly collaborative teams
  • Professional development, education assistance, certification and training opportunities
#GDITHealth#GDITHealthSystems#MilitaryHealthGDITJobs#GDITPriority

Work Requirements
Years of Experience

5 + years of related experience

* may vary based on technical training, certification(s), or degree

Certification

Travel Required

None

Citizenship

U.S. Citizenship Required

About Our Work

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.