SAS Programmer

Tunnell Government Services; Bethesda (MD); On-site; USD 90,000 - 150,000; Full time

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.

Skills

SAS programming

CDISC SDTM

Clinical data management

Tools

SAS

Job description

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions.

Title: SAS Programmer

Deliverables

• Prepare, update, and maintain all versions of statistical analysis plans
• Prepare, update, and maintain all versions of Statistical Programming Validation Plans, and all versions of statistical programming validation reports; Develop and provide statistical program formats used in the statistical programs (all versions)
• Prepare, update, and maintain all versions of randomization plans including randomization list(s) and key(s), prepare statistical programs used to create randomization list(s) and key(s)
• 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 and revise as required statistical programming specifications used to create CDISC-compliant datasets, SDTM, Analysis Data Model 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 Analysis Data Model datasets conforming to CDISC standards as required
• Develop and update as required by CDISC Reviewer’s Guides
• Provide written responses to sponsor and FDA requests/queries regarding statistical products

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.