Senior Director, Head of Statistical Programming

The role

The Head of Statistical Programming will lead the strategy, organization, and delivery of statistical programming across the clinical portfolio. This person will build and develop the internal programming team, oversee CRO partnerships, and establish scalable programming standards.

What you will do

• Build, lead, and develop a high-performing Statistical Programming organization
• Develop, implement, and maintain SOPs and programming standards
• Define and evolve the Statistical Programming operating model
• Provide strategic and operational leadership for clinical development programs
• Lead programming strategy and execution for regulatory submissions including NDA/BLA filings
• Oversee the development of SDTM, ADaM, define.xml, and reviewer guides
• Serve as the senior Statistical Programming representative for regulatory inspections and audits
• Establish and maintain programming standards, SOPs, and validation frameworks
• Develop and execute sourcing strategies using internal resources, CROs, and contractors
• Manage departmental resources, budgets, capacity planning, and vendor performance

Required qualifications

• Master's degree or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative field
• 10+ years of statistical programming experience within the pharmaceutical, biotechnology, or clinical research industry
• Proven experience leading and managing a team of statistical programmers
• Demonstrated experience leading major regulatory submissions, including NDA/BLA filings and health authority interactions
• Deep expertise in SAS
• Comprehensive knowledge of CDISC standards (SDTM and ADaM), regulatory submission requirements, define.xml, reviewer guides, and electronic submission packages
• Strong understanding of the clinical development lifecycle, statistical analysis, study reporting, submission readiness, and regulatory compliance
• Experience managing vendors, CROs, outsourced deliverables, budgets, and resource planning
• Experience supporting regulatory inspections, audits, validated computing environments, and data integrity requirements
• Ability to provide strategic leadership while remaining technically credible and hands-on when needed

Nice to have

• Experience in cardiovascular clinical development is desirable
• Expertise in R, modern open-source programming practices, and version-control platforms such as Git

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. The company has a cutting-edge discovery and translational research platform and a pipeline of late-stage candidates.