Director of Statistical Programming

A company is looking for a Director, Statistical Programming.

Key Responsibilities

Lead and manage statistical programming activities for clinical studies, ensuring high-quality deliverables and adherence to timelines

Collaborate with biostatisticians and cross-functional teams to define programming strategies and requirements

Develop, validate, and maintain analysis datasets and related outputs in compliance with regulatory guidelines

Required Qualifications

MS degree in Statistics, Computer Science, Mathematics, or a related field

At least 12 years of experience in the pharmaceutical industry, with supervisory experience preferred

Thorough understanding of ICH Guidelines, regulatory requirements, and CDISC standards

Direct experience with NDA / BLA or other regulatory filings

Demonstrated experience in departmental resource allocation