Head of Statistical Programming – Oncology Trials

Summit Therapeutics; Palo Alto (CA); On-site; USD 203,000 - 253,000; Full time

Job summary

Summit Therapeutics Inc. seeks a Director of Statistical Programming to lead clinical trial programming, ensuring regulatory submissions and data workflows across NDA/BLA programs. You will mentor staff, coordinate with Biostatistics, Data Management, and CROs, and shape governance for complex data analyses using ADaM/SDTM.

The role requires strong SAS/R expertise, oncology trial experience, and excellent communication in a fast-paced environment.

Qualifications

• PhD or MS with substantial experience in statistics/biostatistics in clinical trials.
• Experience leading statistical programming for oncology phase II/III studies.
• Proven track record with regulatory submissions (NDA, sNDA, BLA).
• Deep knowledge of CDISC standards and ADaM/SDTM development.
• Strong communication and ability to work with cross-functional teams.

Responsibilities

• Provide technical and/or operational leadership for statistical programming in clinical studies.
• Collaborate with Biostatistics to implement analyses and ADaM specifications.
• Oversee CDISC SDTM/ADaM datasets and regulatory submission support.
• Manage internal and vendor statistical programming resources and governance.
• Develop programming standards and reusable macros to improve efficiency.
• Ensure accuracy, timeliness, and regulatory compliance across projects.

Skills

Statistical programming leadership

Regulatory submissions

CDISC standards

SAS programming

R programming

Communication skills

Project management

Regulatory knowledge

Independent work

Collaboration

Education

PhD in statistics/biostatistics

MS in statistics/biostatistics

Tools

SAS

R

EAST

Job description

Summit Therapeutics Inc. seeks a Director of Statistical Programming to lead clinical trial programming, ensuring regulatory submissions and data workflows across NDA/BLA programs. You will mentor staff, coordinate with Biostatistics, Data Management, and CROs, and shape governance for complex data analyses using ADaM/SDTM.

The role requires strong SAS/R expertise, oncology trial experience, and excellent communication in a fast-paced environment.