Senior Statistical Programmer I & II

Job description

Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.

Develop SDTM specifications and generate SDTM datasets using SAS.

Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.

Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.

Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).

Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.

Analyze information and develop innovative solutions to programming and data analysis challenges.

Actively communicate with statisticians for statistical input and analysis interpretation.

Follow and reinforce regulatory agency requirements during daily job.

Serve as a programming team lead and contribute to department initiative.

Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.

Review draft and final production deliverables for project to ensure quality and consistency.

Candidate Profile:

Master s / Bachelor s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.

Should have 8-13 years of experience in Statistical Programming in Clinical domain.