Associate Director, Biostatistics

Job Title: Associate Director, Biostatistics

Location: Menlo Park, CA, US or Remote

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

Summit Activities

We have in-licensed Ivonescimab, which 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. We plan to initiate phase-III clinical studies in the following NSCLC indications:

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)

Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.

Overview of Role:

Serves as the study level biostatistician including participating in study design and protocol review discussion, conducting sample size calculations, developing statistical analysis plan, data presentation plan and DMC charter, reviewing study documents (e.g. CRFs, ADaM specifications, statistical outputs, and etc.) for multiple clinical trials in oncology. Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results, and assists in development and review of regulatory submission documents. Implements biostatistics department policies, standards, procedures, and work-instructions. Represents biostatistics function in interactions with CROs and other vendors.

Role and Responsibilities:

• Provide statistical support to clinical development through the design and conduct of multiple clinical studies in oncology
• Participate in cross-functional protocol design and review discussions, and support protocol development to ensure appropriateness of trial design, sample size, and statistical methodologies
• Lead development of statistical analysis plan, data presentation plan, DMC charter, and other relevant documents by collaborating with cross-functional partners to meet project timelines
• Review the accuracy/consistency of clinical data and statistical outputs, perform ad-hoc statistical analysis, interpret study results, and collaborate with cross-functional partners to produce interim reports, final reports, scientific publications, and internal/external presentations
• Collaborate with clinical operations, data management, statistical programing and CRO to develop and implement CRFs, database design, and the overall data quality plan
• Review vendor data transfer specifications and ADaM programming specifications
• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
• Assist in the development and review of documents required for regulatory submissions and other regulatory processes
• Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results
• Comply with applicable corporate and divisional policies, procedures and culture values, and ensure compliance with department standards, GxP and best operating practices
• Contribute to developing department standards

Experience, Education and Specialized Knowledge and Skills:

• PhD or MS with at least 5-8 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
• Comprehensive knowledge of FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards
• Advanced knowledge of CDISC requirements
• Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc.
• Excellent interpretation and presentation skills
• Excellent organizational skills and attention to detail

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