Senior Statistical Programmer Analyst

Job Summary

Working remotely as a contractor, the Senior Statistical Programmer Analyst will support the submission readiness of study data packages per CDISC standards and FDA guidance, manage statistical programming infrastructure, and collaborate with biostatisticians and clinical data managers.

Key responsibilities

• Develop specifications and execute programs for internal data reviews, regulatory submissions, and exploratory analyses
• Adopt a strategic approach to prioritize analytical deliverables, including safety signal detection analyses
• Create and review SDTM/ADaM mapping specifications and validate datasets and TFLs for clinical studies

Required qualifications

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