Director, Biostatistics

Summit Therapeutics Sub•Menlo Park, CA

2d•$163,000 - $191,000

About The Position

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summits core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: Serves as the study-level biostatistician including reviewing protocol, conducting sample size calculations, developing statistical analysis plan, data presentation plan, and Data Monitoring Committee (DMC) charter, reviewing study documents (e.g., CRFs, ADaM specifications, statistical outputs, etc.) for 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 the development and review of regulatory submission documents. Implements biostatistics department policies, standards, procedures, and work instructions.

Requirements

Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required.
MS degree in related discipline with extensive industry and leadership experience (8+ years) can be considered.
Strong proficiencies in software and other tools typically used by Biostatistics (e.g. SAS, R)
Good understanding of clinical trial processes and statistical programming requirements
Working knowledge of ICH, FDA and GCP regulations and guidelines
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication skills
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
Communicate effectively and articulate complex ideas in an easily understandable way
Work in a fast-paced, demanding and collaborative environment

Responsibilities

Provide statistical support to clinical development through the conduct of clinical studies in oncology
Conduct sample size calculations and develop statistical analysis plans (SAPs), data presentation plans, and DMC charters.
Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
Review study documents (e.g., protocol, vendor data transfer specifications, ADaM specifications, statistical outputs) for clinical trials in oncology.
Review the accuracy of clinical data, perform statistical analysis, ensure the application of appropriate statistical methods, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final clinical study reports
Contribute to the preparation of manuscripts for publication, ensuring accurate statistical reporting of research findings.
Develop and implement new statistical methodologies that enhance study design and analysis
Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
Independently defines required resources for assigned work, seeking advice as needed.
Work with department leader to develop and implement department policies, standards and procedures
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and company SOPs.