Clinical Application Specialist III

Job Description

Safeguarding 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/ISE ADaM programming and submissions
Developing and reviewing TLF outputs

Experience/Skills

• 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, ISE 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 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.

Pay

Target PR Range: 53-63/hr Depending on experience