Principal Statistical Programmer Consultant

Job Summary

Working remotely, the Principal Statistical Programmer Consultant will engage in CRF design, produce data listings and summary tables, and coordinate data transfers while ensuring compliance with programming standards in a client-facing role.

Key responsibilities:

• Participate in CRF design, database review, and data validation procedures
• Produce data listings and summary tables for interim and final analyses
• Coordinate data transfer and programming standards with CROs and vendors

Required qualifications:

• Minimum of 10 years of SAS programming experience in the pharmaceutical or biotechnology industry
• Expertise in SAS programming language and CDISC data standards
• Experience as a senior statistical programmer in an FDA-regulated environment
• BA/BS in computer science, statistics, or math; or MA/MS with 8 years of experience
• Familiarity with Clinical Study Reports and NDA submission processes