Director, Biostatistics

Responsibilities

• Provide technical leadership and statistical support for oncology clinical studies
• Support protocol development, including trial design and sample size determination
• Lead development of statistical analysis plans, data presentation plans, and regulatory submission activities
• Review clinical data accuracy, perform statistical analysis, and interpret study results
• Write and review regulatory submission documents and meeting packages
• Review vendor data transfer and ADaM programming specifications
• Collaborate with clinical operations, data management, and CROs on database design and data quality
• Manage CROs and vendors regarding scope, timelines, and budgets
• Represent the biostatistics function in cross-functional teams and regulatory meetings

Requirements

• PhD with 8+ years of experience or MS with 11+ years of experience in statistics or biostatistics
• Experience in oncology Phase II/III clinical studies
• Experience driving regulatory submissions such as NDA, sNDA, or BLA
• In-depth knowledge of CDISC standards
• Technical expertise in SAS, R, or EAST
• Working knowledge of ICH, FDA, and GCP regulations
• Excellent written and verbal communication skills

About the Company

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies in oncology.