Clinical Application Specialist III (Clinical SAS Programmer)
Job Description
Support safety and efficacy analyses for Immunology clinical trials. Develop ADaM specifications and ADaM datasets from aCRFs, SDTM datasets, SAPs, and SPPs to support Clinical Study Reports (CSRs). Program, validate, and review Tables, Listings, and Figures (TLFs) for clinical studies. Support Integrated Summary of Safety (ISS) and regulatory submission deliverables. Perform quality control and validation of programming outputs to ensure accuracy and compliance. Collaborate with statisticians, data management, and clinical programming teams to deliver high-quality analysis datasets and reports. Interpret CDISC standards and regulatory requirements while utilizing internal programming macros and tools, including Pinnacle 21. Contribute to project planning and ensure programming deliverables are completed within established timelines.
Required Skills
- Bachelor’s degree required
- 6 to 8+ yrs of SAS programming experience, preferably in UNIX environment, supporting clinical trials data analysis
- Enterprise Guide experience is a plus
- Solid CDISC Standards knowledge, 8+ years of ADaM and TLF programming experience supporting safety and efficacy analysis
- Immunology TA experience is preferable but not required
- Well experienced in converting information from aCRF, SDTM data, SAP and SPP into ADaM specifications and review TLF outputs from vendors
- Experienced in supporting ISS, Client ADaM programming and submissions
- Ability to quickly learn internal macros, processes and interpret Pinnacle 21 results
- Team player with excellent communication skills and experience working with stat programmers, statisticians and data management personnel
Preferred Qualifications
- Experience supporting Immunology clinical trials
- Experience with SAS Enterprise Guide
- Familiarity with Pinnacle 21 validation and internal SAS macros