Summit Therapeutics, Inc.
Director Biostatistics
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
Overview
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, HARMONi-3 and HARMONi-7, evaluating ivonescimab in combination with chemotherapy or as monotherapy in different NSCLC settings. Ivonescimab is an investigational therapy not approved by regulatory authorities in Summit’s license territories, including the United States and Europe. It was approved for marketing authorization in China in May 2024 and has Fast Track designation by the FDA for the HARMONi trial setting. Role overview: 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 teams in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring delivery and interpretation of clinical data. Develops and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with the department leader and other functions. Represents the 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 and contribute to protocol development to ensure appropriateness of trial design, sample size, and 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 analyses, interpret study results, and collaborate with the clinical team to produce interim and final reports and publications Write or review sections of meeting packages and assist in the development and review of documents required for regulatory submissions and processes Review vendor data transfer specifications and ADaM programming specifications Lead assessment and introduction of novel statistical methodologies to implement solutions Represent the biostatistics function or biometrics department in cross-functional teams Work with the 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 with a minimum of 8+ years of experience or a Masters (MS) with a minimum of 11+ years of experience in statistics or biostatistics related to clinical trials in pharma/biotech or healthcare Experience in supporting oncology phase II/III clinical studies Experience in regulatory submissions (e.g., NDA, sNDA, BLA) In-depth knowledge of CDISC standards Technical expertise in experimental design and analyses using SAS, R, or EAST Excellent written and verbal communication skills Good working knowledge of ICH, FDA and GCP regulations and guidelines
Seniority level
Director
Employment type
Full-time
Job function
Research
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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, HARMONi-3 and HARMONi-7, evaluating ivonescimab in combination with chemotherapy or as monotherapy in different NSCLC settings. Ivonescimab is an investigational therapy not approved by regulatory authorities in Summit’s license territories, including the United States and Europe. It was approved for marketing authorization in China in May 2024 and has Fast Track designation by the FDA for the HARMONi trial setting. Role overview: 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 teams in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring delivery and interpretation of clinical data. Develops and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with the department leader and other functions. Represents the 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 and contribute to protocol development to ensure appropriateness of trial design, sample size, and 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 analyses, interpret study results, and collaborate with the clinical team to produce interim and final reports and publications Write or review sections of meeting packages and assist in the development and review of documents required for regulatory submissions and processes Review vendor data transfer specifications and ADaM programming specifications Lead assessment and introduction of novel statistical methodologies to implement solutions Represent the biostatistics function or biometrics department in cross-functional teams Work with the 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 with a minimum of 8+ years of experience or a Masters (MS) with a minimum of 11+ years of experience in statistics or biostatistics related to clinical trials in pharma/biotech or healthcare Experience in supporting oncology phase II/III clinical studies Experience in regulatory submissions (e.g., NDA, sNDA, BLA) In-depth knowledge of CDISC standards Technical expertise in experimental design and analyses using SAS, R, or EAST Excellent written and verbal communication skills Good working knowledge of ICH, FDA and GCP regulations and guidelines
Seniority level
Director
Employment type
Full-time
Job function
Research
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