Principal Statistical Programmer

Role Overview

• Meetings and communications
• Generate SDTM and ADaM specifications
• Generate & QC assigned dataset domains
• Support submission activities
• Generate TLFs (patient profile, interim analysis, annual summary report, final CSR)
• Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s)
• Handling Data transfers to sponsor (or other designee)
• Publication support
• Ad hoc tasks/activities requested by sponsor
• Writing SAS macros and other utilities and tools
• Reviewing documents/specifications/output created by sponsor’s Partner CROs
• Maintenance of associated tracking and validation documentation

Requirements

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
• 8+ years of experience as a Statistical Programmer in clinical Development environment
• Excellent SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
• Prior working experience with Oncology studies
• Must be able to work independently
• Outstanding communication skills (written and verbal) and strong leadership skills

Benefits

• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
• Consistent training, development and support.