Associate Director / Director Of Statistical Programming

Associate Director / Director of Statistical Programming Overview

• Lead statistical programming initiatives in clinical development, ensuring compliance with CDISC standards and regulatory requirements.
• Collaborate with cross-functional teams to define programming needs, timelines, and deliverables.
• Develop and maintain SAS macros, programming standards, and validation processes for clinical data analysis.
• Utilize GitHub or GitLab for version control, code review, and programming workflow management.
• Support R-based programming solutions, including R Shiny applications, for clinical data visualization and reporting.
• Provide technical oversight and mentorship to programming teams and external resources.
• Contribute to regulatory submission preparation and respond to agency data requests.
• Advise on programming strategy, resourcing, and departmental priorities for Director-level consultants.

Associate Director / Director of Statistical Programming Key Responsibilities & Duties

• Provide leadership across clinical programming activities, ensuring quality and compliance with standards.
• Plan, develop, review, and deliver SAS programming outputs, including datasets and documentation.
• Collaborate with Biostatistics, Clinical Data Management, and other teams to meet project objectives.
• Enhance programming efficiency through automation and reproducibility improvements.
• Develop R-based solutions for data visualization and operational insights.
• Ensure programming deliverables meet regulatory expectations and inspection readiness.
• Provide mentorship and technical guidance to programming teams and external vendors.
• Support regulatory submission preparation and post-submission programming needs.

Associate Director / Director of Statistical Programming Job Requirements

• Bachelor’s degree in Statistics, Biostatistics, Computer Science, or related field; advanced degree preferred.
• 8+ years of clinical statistical programming experience; 10+ years preferred for Director-level roles.
• Extensive SAS programming experience in regulated clinical research environments.
• Strong knowledge of CDISC standards and global regulatory submission requirements.
• Proficiency in GitHub or GitLab for version control and programming workflows.
• Experience with R programming and R Shiny application development.
• Python experience preferred for automation and data visualization.
• Proven ability to lead programming teams and manage external resources effectively.