Clinical Application Specialist III - # 26-18520

• Supporting safety and efficacy analysis in Immunology projects.
• Interpreting information from aCRF, SDTM data, SAP, and SPP to develop ADaM specifications and ADaM datasets to support CSRs.
• Supporting ISS/Client ADaM programming and submissions.
• Develop and review TLF outputs.

• 6-8+ 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.

Back-up contact for programming of tables, listings, and graphs for a specified compound project. Responsible for the validation and quality assurance of any output produced for specified projects and contributing to al project management such that timelines are met. Back-up participant on Clinical Project teams representing clinical programming efforts for that clinical team. Prefer candidate with clinical experience. SAS program experience required.