Clinical Application Specialist III

Position Title: Clinical Application Specialist III

Work Location: Remote or hybrid in Lake County / SFO/NJ site

Assignment Duration: 12 months (possibility of extension)

Position Summary:

Complete assignments from lead programmers on time and with good quality; provide updates to study lead programmer and peer programmers as needed. ADaM programming and validation, TFL programming and validation, additional quality review of statistical programing deliverables; communicate with programming team on issues of various types.

Key Responsibilities:

* Complete assignments from The Organization lead programmers on time and with good quality; provide updates to study lead programmer and peer programmers as needed.

* ADaM programming and validation, TFL programming and validation, additional quality review of statistical programing deliverables; communicate with programming team on issues of various types.

Qualification & Experience:

* 5+ yrs of experience in Statistical Programming using SAS preferably in UNIX environment, supporting clinical trials data analysis. Enterprise Guide experience is a plus.

* Solid CDISC Standards knowledge, and solid ADaM programming experience including both safety and efficacy analyzes. Oncology TA experience is preferred.

* Experienced in supporting ISS, ISE ADaM programming and submissions is a plus.

* 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.