SAS Programmer – CDISC, SDTM & FDA Reporting

Tunnell Government Services

Bethesda (MD)

On-site

USD 90,000 - 150,000

Full time

14 days+

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Job summary

Tunnell Government Services, Inc. is seeking a SAS Programmer to support statistical programming for clinical studies. The role involves developing and maintaining analysis plans, validation reports, and CDISC-compliant datasets in a regulated environment.

The candidate will produce tables, listings, and figures for studies and FDA-related reports. The position emphasizes collaboration with sponsors and FDA communications, adherence to CDISC standards, and delivering high-quality statistical

Qualifications

Experience delivering SAS-based analysis plans and reports.
Familiarity with CDISC SDTM datasets and standards.
Ability to work with clinical data and regulatory reporting requirements.

Responsibilities

Prepare, update, and maintain all versions of statistical analysis plans.
Prepare, update, and maintain all versions of Statistical Programming Validation Plans and reports; develop programming formats.
Prepare randomization plans and develop programs for randomization lists and keys.
Develop statistical programming specifications for CDISC datasets and SDTM/ADaM datasets.
Create data-populated tables, listings, and figures for studies and reports.
Develop define.xml and SEND datasets per CDISC standards when applicable.
Respond to sponsor/FDA inquiries regarding statistical products.