Executive Director, Biostatistics

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. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials :

• HARMONi : Phase III trial evaluating ivonescimab combined with chemotherapy versus placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC patients who progressed after 3rd generation EGFR TKI (e.g., osimertinib).
• HARMONi-3 : Phase III trial evaluating ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy in first-line metastatic NSCLC.
• HARMONi-7 : Phase III trial evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression.

Ivonescimab is an investigational therapy not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. It was approved for marketing authorization in China in May 2024 and granted Fast Track designation by the US FDA.

Overview of the Role

The Executive Director of Biostatistics serves as the Biostatistics Lead for multiple oncology projects, providing strategic and technical leadership, statistical support, and regulatory submissions. They collaborate with clinical science, regulatory and other functions on clinical development plans, authorship of key clinical, regulatory, statistical documents, and ensuring high-quality delivery and interpretation of clinical data. The Executive Director develops and implements biostatistics department policies, represents biostatistics in interactions with CROs, IRBs, and regulatory agencies, and has direct supervisory responsibilities for internal staff or external consultants.

Role and Responsibilities

Experience, Education, and Specialized Knowledge and Skills

Compensation

The pay range for this role is $224,000–$285,000 annually, with additional bonus, stock, benefits and / or variable compensation. Actual compensation is based on skill set, experience, certifications, and work location.

Referrals

Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x. Summit does not accept referrals from employment businesses or agencies. All referrals must be made directly to Summit’s Talent Acquisition team at recruiting@smmttx.com for prior authorization.

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