Associate Director, Biostatistics at Summit Therapeutics

Job description

About Summit: 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) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. 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. Overview of Role: This position serves as the project level biostatistician providing technical leadership and statistical expertise to the design and execution of late-stage oncology clinical trials. They will contribute to protocol development, author the statistical analysis plans, conduct statistical analyses, and oversee biometrics activities for regulatory submissions. This position will collaborate with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data. The Senior Director will develop and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions. They will represent biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies. Role and Responsibilities: Provide technical leadership and statistical expertise in the design and execution of late-stage oncology clinical trials Contribute to protocol development, ensuring trial design, sample size, and statistical methodologies are appropriate and efficient Lead the development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses Review clinical data for accuracy, perform statistical analyses, interpret study results, and collaborate with cross functional teams to produce interim and final reports, as well as 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 le