Principal Statistical Programmer Consultant - job 1 of 3

Job Summary

A company is looking for a Principal/Lead Statistical Programmer Consultant (Cardiovascular) to support clinical trials and regulatory submissions.

Key Responsibilities

• Serve as the principal programming lead across multiple studies, ensuring timely and regulatory-compliant deliverables
• Lead the development, validation, and documentation of SDTM, ADaM, and TFLs for clinical study reports and regulatory submissions
• Collaborate with cross-functional teams to review specifications and ensure programming deliverables meet regulatory standards

Required Qualifications

• Master's degree in Statistics, Biostatistics, Computer Science, or a related field
• Minimum of 8 years of statistical programming experience in the pharmaceutical, biotech, or CRO environment
• Expert-level SAS programming skills; proficiency in R is highly desirable
• Deep understanding of CDISC standards (SDTM, ADaM) and regulatory submission requirements
• Experience with tools like Pinnacle 21 and define.xml, along with a strong knowledge of clinical trial design and data standards