Senior Statistical Programmer Analyst

Job Summary

To support submission readiness of study data packages, the remote Senior Statistical Programmer Analyst Contractor will develop specifications, execute programming for data reviews, and ensure quality delivery of analyses while collaborating with biostatisticians and clinical teams.

Key responsibilities

• Develop specifications and execute programs for internal data reviews, publications, and regulatory analyses
• Manage on-time and quality delivery of CRO-generated analysis results while adopting a strategic approach to analytical deliverables
• Create and review SDTM/ADaM mapping specifications and validate datasets for clinical studies and regulatory submissions

Required qualifications

• Bachelor's or Master's degree in a data science field such as statistics, mathematics, or bioinformatics
• 8+ years of programming experience in a biotechnology or pharmaceutical clinical trial environment
• Expertise in software development and testing, including SAS, R, and Python
• Solid understanding of CDISC standards, specifically SDTM and ADaM
• Basic project management skills and experience with relevant health authority guidelines