Director, Biostatistics

Location

On‑Site 4 days per week at our Menlo Park, CA, Miami, FL, or Princeton, NJ office.

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 (e.g., 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 Summit’s 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 United States Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview Of Role

Serves as the project level biostatistician and provides leadership within the biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology.

Partners 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. Develops and implements biostatistics department policies, standards, procedures, and work‑in‑instructions in coordination with the department leader and other functions. Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.

Responsibilities

Experience, Education And Specialized Knowledge And Skills

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Seniority Level

Director

Employment Type

Full‑time

Job Function

Strategy / Planning and Information Technology

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