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# Clinical SAS Programmer

- **Company:** Katalyst Talent Agency
- **Location:** Edison, NJ, United States
- **Contract:** Permanent contract
- **Skills:** Data Analysis, Computer Programming, Coherent Remote File System (CRFS), SAP (Applications), SAS (Software), Distributed Temperature Sensing (DTS), Macros, Data Management
- **Published:** September 18, 2026
- **Apply:** https://www.careerjet.com/job/usc1ce8afc2f73ead3a8bf18a55be1ea8b/eaa

## About the Role

* Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
 * Thorough knowledge of SDTM/ADaM specifications and programming
 * Strong SAS programming and graphic programming skills
 * Able to guide the successful completion of major programs and projects.
 * Strong analytical and communication skills
 * Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies.
 * Broad knowledge of medical/biological terminology in relevant therapeutic areas.
 * Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings.
 * Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses.
 * Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus.
 * Experience in management of CROs with respect to statistical programming.

## Description

* Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget.
 * Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences.
 * Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications.
 * Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc.
 * Ensure timely delivery of all statistical deliverables for each study assigned.
 * Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items.
 * Follow departmental SOPs and processes for operational excellence.
 * Lead statistical programming activities for regulatory submissions following CDISC standards.
 * Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan.
 * Take ownership for the completion of SDTM and ADAM specifications for assigned studies., Responsibilities: Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. Be responsible for overall project delivery, including cli…
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