Director, Biostatistics

The role

The Director, Biostatistics provides leadership to develop and execute statistical strategy, study design, and regulatory submissions for oncology clinical trials. This person partners with clinical science and regulatory teams to ensure delivery and interpretation of clinical data.

What you will do

• Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology
• Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies
• Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses
• Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team to produce reports and publications
• Write/review sections of meeting packages and assist in the development and review of documents required for regulatory submissions
• Review vendor data transfer specifications and ADaM programming specifications
• Lead assessment and introduction of novel statistical methodologies to implement solutions
• Represent biostatistics function or biometrics department in cross function teams
• Work with department leader to develop and implement department policies, standards and procedures
• Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan

Required qualifications

• PhD and a minimum of 8+ years of experience or Masters (MS) and a minimum of 11+ years of experience in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech
• Experience in supporting oncology phase II/III clinical studies
• Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA)
• In-depth knowledge of CDISC standards
• Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc.
• Excellent written and verbal communication skills
• Good working knowledge of ICH, FDA and GCP regulations and guidelines

Benefits

• bonus
• stock
• benefits
• other applicable variable compensation

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.