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 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:

• Education: Bachelor’s Degree in Computer Science, Statistics or a related discipline, or the equivalent combination of education, professional training, or work experience.

• Required Experience: 5 years of related SAS programming experience.

• Required Technical Skills: Knowledge of CDISC standards

• Excellent written and oral communication skills.

• Location: Onsite Ft Detrick Frederick, MD

• US Citizenship Required: Must be U.S. citizen and be able to obtain a T1.

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