Head of Statistical Programming — Strategic Leader

Kardigan; Princeton (NJ); On-site; USD 248,000 - 323,000; Full time

Job summary

Kardigan is seeking a Senior Director, Head of Statistical Programming to guide strategy, organization, and quality of programming across its cardiovascular portfolio. The role will lead internal teams and oversee CRO partnerships, establishing scalable standards and a compliant environment for regulatory submissions.

Ideal candidates bring 10+ years in statistical programming within pharma/biotech, strong CDISC expertise, and proven vendor management.

Qualifications

• Master's degree or PhD in a quantitative field.
• 10+ years of statistical programming experience in pharma/biotech.
• Proven experience leading a team of statistical programmers.
• Demonstrated experience leading regulatory submissions (NDA/BLA) and health authority interactions.
• CDISC SDTM/ADaM knowledge and familiarity with define.xml and submission packages.
• Experience managing vendors, CROs, budgets, and resource planning.

Responsibilities

• Lead Statistical Programming organization and oversee CROs/contractors.
• Ensure timely delivery of analysis datasets, tables, figures, listings, and documentation.
• Oversee SDTM, ADaM, define.xml, and submission components per regulatory standards.
• Maintain programming standards, validation frameworks, and QA processes.
• Collaborate with Biostatistics, Data Management, Regulatory, Quality, and IT.

Skills

Leadership

Regulatory submissions

Cross-functional collaboration

Vendor management

Strategic planning

Education

Master's degree or PhD in Statistics/Biostatistics/Math/CS

Tools

SAS

R

Git

Job description

Kardigan is seeking a Senior Director, Head of Statistical Programming to guide strategy, organization, and quality of programming across its cardiovascular portfolio. The role will lead internal teams and oversee CRO partnerships, establishing scalable standards and a compliant environment for regulatory submissions.

Ideal candidates bring 10+ years in statistical programming within pharma/biotech, strong CDISC expertise, and proven vendor management.