Associate Director, Biostatistics

Associate Director, Biostatistics

Palo Alto, California, United States

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. Summit's 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.

Summit's team is inspired to touch and help change lives through Summit's 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 China's 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.

Role and 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.

Experience, Education and Specialized Knowledge and Skills:

• 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

This is the pay for this position

Pay Transparency

$190,000 - $210,000 USD

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.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at View email address on click.appcast.io to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.