Associate Director/Director, Statistical Programming

Role overview

Leadership and strategy

• Lead and manage statistical programmers; establish organizational structure, hiring plans, and career development frameworks.
• Mentor and manage performance for senior managers, leads, and staff programmers.
• Define global programming strategy and oversee support for Phase I–IV trials, integrated summaries, and submissions.
• Contribute to corporate planning, budget forecasting, resource allocation, and vendor partnerships.

Technical delivery and collaboration

• Ensure quality SDTM and ADaM datasets, tables, listings, and figures.
• Lead submission planning and execution, including eCTD packages and Define.xml generation.
• Govern global CDISC standards and compliance; represent programming in leadership forums and regulatory interactions.
• Collaborate with internal functions and external partners, and oversee CRO and technology vendor relationships.

Process improvement

• Champion programming workflow optimization, automation, and innovation.
• Evaluate and implement tools and technologies, including R, Python, and cloud-based analytics.
• Maintain compliance with industry standards, company SOPs, and regulatory expectations.

Qualifications

• Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field is required.
• 12+ years of statistical programming experience in pharmaceutical, biotech, or CRO settings is required.
• Five years managing programming teams is required.
• Vendor and CRO partnership management experience is preferred.
• Expert SAS knowledge, deep CDISC SDTM and ADaM familiarity, and experience supporting NDA, BLA, and MAA submissions are required.
• Knowledge of ICH guidelines, 21 CFR Part 11, and global regulatory requirements is required.
• Strong communication, collaboration, and leadership skills are required.

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