Associate Director, Biostatistics

Responsibilities

• Provide statistical support to clinical development through the conduct of clinical studies in oncology
• Conduct sample size calculations and develop statistical analysis plans (SAPs), data presentation plans, and DMC charters
• Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
• Review study documents including protocols, vendor data transfer specifications, ADaM specifications, and statistical outputs
• Review the accuracy of clinical data, perform statistical analysis, and interpret study results to produce interim and final clinical study reports
• Contribute to the preparation of manuscripts for publication
• Develop and implement new statistical methodologies to enhance study design and analysis
• Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring
• Adhere to regulatory requirements, industry standards, and company SOPs

Requirements

• Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience
• MS degree in related discipline with 8+ years of extensive industry and leadership experience
• Strong proficiency in SAS and R
• Good understanding of clinical trial processes and statistical programming requirements
• Working knowledge of ICH, FDA, and GCP regulations and guidelines
• Excellent oral and written communication skills

About the Company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.