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 US Food & Drug Administration (FDA) for the HARMONi clinical trial setting .

Overview of Role

Serves as the project level biostatistician and provides leadership within 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-instructions in coordination with department leader and other functions. Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.

Role and 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.

Experience, Education and Specialized Knowledge and Skills

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.

The pay range for this role is $184,500 – $230,000 per year. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and / or other applicable variable compensation.

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