Principal Statistical Programmer

Job Summary

A company is looking for a Sr./Principal, Statistical Programmer.

Key Responsibilities

• Provide technical and project management leadership in SAS programs for analyzing and reporting clinical trial data
• Ensure compliance with company SOPs and FDA/ICH/GCP regulations while creating and reviewing necessary documentation
• Conduct briefings and participate in technical meetings with internal and external stakeholders

Qualifications

• Experience with BLAs, MAAs, and other regulatory submissions is a plus
• Proven expertise in all SAS language, procedures, and options used in clinical trial reporting
• MS in biostatistics or a related field with 8+ years of experience in the pharmaceutical industry, or BS with 10+ years of experience
• Highly evolved written and oral presentation skills
• Excellent communication skills with the ability to influence across multiple functions