Executive Director, Biostatistics

Summit Therapeutics plc•Menlo Park, CA

60d•$224,000 - $285,000

About The Position

About Summit Ivonescimab known as SMT112 is a novel potential first in class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD 1 with the anti angiogenesis effects associated with blocking VEGF into a single molecule Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD 1 and VEGF Summit has begun its clinical development of ivonescimab in non small cell lung cancer NSCLC with three active Phase III trials HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI eg osimertinib HARMONi 3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLC HARMONi 7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC whose tumors have high PD L1 expression Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe Ivonescimab was approved for marketing authorization in China in May 2024 Ivonescimab was granted Fast Track designation by the US Food & Drug Administration FDA for the HARMONi clinical trial setting Overview of Role The Executive Director of Biostatistics serves as the Biostatistics Lead for multiple oncology projects providing strategic and technical leadership as well as statistical support in the development and execution of statistical strategies study designs statistical analyses and regulatory submissions They will collaborate with clinical science regulatory and other functions on clinical development plans the authorship of key clinical regulatory statistical documents and ensuring the high quality delivery and accurate interpretation of clinical data The Executive Director will develop and implement biostatistics department policies standards procedures and work instructions in coordination with the department leader and other functions Additionally they will represent biostatistics function in interactions with CROs institutional review boards and regulatory agencies This role includes direct supervisory responsibilities for internal staff or external consultants

Requirements

PhD in Statistics Biostatistics or equivalent area with 15 years biopharmaceutical industry experience or MS degree in related discipline with extensive industry and leadership experience with 18 years biopharmaceutical industry experience required
A minimum of 3 years of experience in team leadership and managing direct reports is required
10 years of experience in oncology clinical trials including trial design and execution with a strong background in late stage clinical trials
Extensive knowledge of clinical trial development and statistical methodologies related to trial design and execution is required with experience in late stage oncology trials and regulatory submissions essential
Comprehensive knowledge of ICH FDA and GCP regulations and guidelines with strong well rounded technical skills
Excellent organizational skills
Critical thinking problem solving ability to work independently
Must be able to effectively multi task and manage time sensitive and highly confidential documents
Communicate effectively and articulate complex ideas in an easily understandable way
Prioritize conflicting demands
Work in a fast paced demanding and collaborative environment

Nice To Haves

Experience in providing statistical support for Medical Affairs and Market Access activities is highly preferred
Experience interacting with health authorities

Responsibilities

Serve as the Biostatistics Lead for multiple oncology projects
Provide strategic and technical leadership along with statistical support to clinical development in the design and conduct of late stage oncology trials
Provide strategic input and guidance to ensure the high quality of Regulatory Authority documents including clinical protocols statistical analysis plans study reports briefing books submissions and safety reports
Collaborate with cross functional teams to ensure accurate interpretation of study results and high quality study reports and publications
Write and review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and processes
Lead the assessment and implementation of novel statistical methodologies to drive solutions
Represent the biostatistics function or biometrics department in cross functional teams
Collaborate with the department leader to develop and implement policies standards and procedures
Develop strong collaborative relationships with key business stakeholders including project leaders in Regulatory Clinical Development Clinical Operations Research and other functions
Assess and manage CROs and other vendors including scope of work timelines deliverables and budgets
Stay up to date with FDA and EMA regulations guidance emerging trial designs for marketing authorization and communicate relevant updates to key stakeholders
Participate in meetings with FDA and other health authorities to ensure alignment on project development
Provide mentorship and coaching to direct reports to help them reach their full potential
All other duties as assigned