Director of Statistical Programming

Job Summary

To support clinical trials from early-stage through regulatory submission, the full-time Director of Statistical Programming will manage programming activities, oversee vendor deliverables, and collaborate with cross-functional teams in a remote work environment.

Key responsibilities

• Lead statistical programming for clinical studies, ensuring high-quality regulatory-compliant deliverables
• Oversee the creation and maintenance of programming plans and statistical analysis plans in collaboration with biostatisticians
• Manage CRO programming activities, providing guidance and quality control for outsourced deliverables

Required qualifications

• Graduate degree in Statistics, Biostatistics, or a closely related field
• 3-5 years of experience in pharmaceutical/biotech programming in a clinical trial environment
• Expert level of SAS programming skills; knowledge of additional programming languages (e.g., R, Python) is a plus
• Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM
• Familiarity with ICH guidelines and regulatory submission requirements