Senior Principal Statistical Programmer

Job Summary

Managing and supporting statistical programming deliverables for multiple clinical studies, the full-time Senior Principal Statistical Programmer will serve as a technical lead and project manager, collaborating cross-functionally to ensure high-quality programming outputs for regulatory submissions and clinical communications in a remote environment.

Key responsibilities:

• Lead and manage multiple studies, overseeing all aspects of statistical and clinical programming deliverables
• Represent the Statistical Programming team in meetings to address project deliverables and timelines
• Write, test, and validate SAS programs for analysis datasets, tables, listings, and graphs for regulatory submissions

Required qualifications:

• Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field, or equivalent experience
• Minimum of 5 years of clinical research programming experience using SAS
• Expert-level knowledge of CDISC methodologies and experience with SDTM and ADaM standards
• Experience leading centralized Statistical Programming teams, particularly in oncology trials
• Familiarity with FDA, EMEA, and CFDA clinical trial and regulatory submissions