Director, Statistical Programming - Oncology Trials

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

Job summary

Summit Therapeutics Inc. is seeking a Director of Statistical Programming to lead the statistical programming team, develop plans for clinical trials, and oversee SAS programs for data analysis and reporting in oncology.

This role ensures adherence to ICH, regulatory standards and CDISC ADaM specifications. The successful candidate will supervise internal and vendor teams, drive standardization across programs, and contribute to NDA and sNDA submissions while coordinating with Biostatistics and

Qualifications

• PhD or MS with extensive experience in statistics for clinical trials.
• Expertise in designing analyses and reporting for regulatory submissions.
• Strong knowledge of CDISC standards and ADaM data structures.

Responsibilities

• Provides technical and/or operational leadership for statistical programming in clinical studies and NDA submissions.
• Collaborates with Biostatistics to implement analyses and develop ADaM specifications.
• Manages internal and vendor statistics programming resources and ensures timely, high-quality deliverables.
• Develops and maintains programming standards and documentation.

Skills

SAS programming

Biostatistics

CDISC standards

Clinical trials

Regulatory submissions

Education

PhD in statistics

MS in biostatistics

Tools

SAS

R

EAST

Job description

Summit Therapeutics Inc. is seeking a Director of Statistical Programming to lead the statistical programming team, develop plans for clinical trials, and oversee SAS programs for data analysis and reporting in oncology.

This role ensures adherence to ICH, regulatory standards and CDISC ADaM specifications. The successful candidate will supervise internal and vendor teams, drive standardization across programs, and contribute to NDA and sNDA submissions while coordinating with Biostatistics and