Senior Statistical Programmer I & II

Job Description

ClinChoice is seeking a Senior Statistical Programmer to contribute to clinical trials. The Senior Statistical Programmer will be responsible for annotating Case Report Forms, developing SDTM and ADaM specifications, and generating datasets using SAS. They will also develop Tables, Listings, Graphs, and Patient Profiles for Clinical Study Reports, Posters, and Manuscripts. The role involves creating electronic submission packages for the FDA and analyzing information to develop innovative solutions to programming and data analysis challenges. Responsibilities:

• 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.

Requirements:

• Master’s / Bachelor’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
• 8-13 years of experience in Statistical Programming in Clinical domain.

The role offers:

• Opportunity to work with a global company.
• Chance to contribute to clinical trials.
• Mentoring and training opportunities.