Director, Biostatistics

Summit Therapeutics•Palo Alto, CA

6d•$203,000 - $253,000

About The Position

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. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC). Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Requirements

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 industry, or healthcare experience
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

Responsibilities

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 and other team members to produce interim reports, final reports, and publications
Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
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
Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success
Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development
All other duties as assigned