- Location
- Bethesda, MD · TGS
- Workplace
- Onsite
Description
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.