SAS Programmer

Program Management and Technology Services, Inc. (PMTS) is seeking a SAS Programmer to support the Defense Health Agency (DHA) Research and Development MRDC Office of Regulated Activities (ORA) at Fort Detrick, MD. This is a contingent position pending award of a federal GSA MAS task order with a target start date of August 1, 2026.

The SAS Programmer is a Designated Key Personnel role providing clinical statistical programming and data analytics support across a portfolio of FDA-regulated medical product development programs. The selected candidate will develop and validate SAS programs that produce CDISC-compliant clinical trial datasets, statistical tables, listings, and figures (TLFs) in support of regulatory submissions including INDs, NDAs, BLAs, 510(k)s, PMAs, and integrated summaries. This role works closely with the Senior Biostatistician, Clinical Database Developer, and Medical Writers to deliver high-quality, submission-ready statistical work products., * Develop, test, validate, and document SAS programs supporting clinical trial analysis, regulatory submissions, and ad hoc statistical reporting per the Statistical Analysis Plan

• Produce CDISC SDTM and ADaM analysis datasets and define.xml metadata in accordance with current FDA and CDER Technical Conformance Guide requirements
• Generate publication-quality Tables, Listings, and Figures (TLFs) for Clinical Study Reports, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), and other regulatory deliverables
• Perform independent programmatic validation (double programming) of statistical outputs and resolve discrepancies in collaboration with lead statisticians
• Develop and execute edit checks, data reconciliation programs, and quality-control routines on clinical trial data, supporting database lock readiness
• Support pharmacokinetic, pharmacodynamic, and exposure-response analyses, including production of PK/PD datasets and supporting deliverables
• Collaborate with the Senior Biostatistician on Statistical Analysis Plan development, sample size calculations, and analytical methodology
• Maintain comprehensive program documentation, version control, and audit trails compliant with 21 CFR Part 11 and applicable ORA standards
• Participate in protocol review, CRF design review, and Data Management Plan development to ensure downstream analyzability of clinical trial data
• Support FDA submission and review activities including responses to FDA information requests and preparation of submission datasets in eCTD-ready format

Do you have experience in Technical writing within healthcare?, Do you have a Bachelor's degree?, * Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Epidemiology, or a related quantitative field; Master's degree preferred

• Minimum 4 years of professional clinical SAS programming experience in pharmaceutical, biotechnology, medical device, CRO, or government clinical research settings
• Demonstrated expertise in Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro Language, and SQL; proficiency in CDISC SDTM and ADaM standards
• Hands-on experience producing TLFs and analysis datasets for at least one regulatory submission (IND, NDA, BLA, 510(k), PMA, or equivalent)
• Working knowledge of ICH E9, FDA Statistical Software Guidance, and 21 CFR Part 11 compliance requirements for electronic records
• Strong written and verbal communication skills; ability to document programming logic and communicate statistical concepts to non-statistical stakeholders
• U.S. citizenship required; ability to obtain and maintain a T1/HSPD-12 Public Trust investigation, * Master's degree (MS, MPH, or equivalent) in Biostatistics, Epidemiology, or Statistics
• CDISC SDTM and/or ADaM Advanced certification
• Experience supporting DoD, NIH, BARDA, or other federal clinical research programs (USAMRDC, WRAIR, Fort Detrick, NCI, or NIAID preferred)
• Working knowledge of R, Python, or other complementary statistical programming environments
• Experience with SEND (Standard for Exchange of Nonclinical Data) for FDA toxicology submissions
• Familiarity with statistical computing environments used in federal research settings (SAS Grid, SAS Viya, or AWS-hosted SAS environments)
• Experience supporting multi-protocol programs, oncology, vaccines, or medical countermeasures

Pulled from the full job description

• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Dental insurance
• Life insurance, * 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance