Principal Statistical Programmer

Job Summary

A company is looking for a Principal Statistical Programmer.

Key Responsibilities

• Lead the development and validation of statistical programs for high-quality deliverables, ensuring compliance with requirements
• Create and review programming plans and specifications, requiring advanced knowledge of CDISC standards
• Review and validate deliverables from CROs and support the preparation of clinical study reports and regulatory submissions

Required Qualifications

• Expert-level SAS programming skills with experience in complex programming assignments
• Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM
• Experience in the drug development process and collaboration with CROs
• Experience with FDA/EMEA/CDE filings
• Bachelor's degree in a computational or biological science with 8 years of related experience, or a Master's degree with 6 years of experience