Associate Director, Biostatistics

Overview

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. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people. Our employees are the heart and soul of our culture, driving Summit’s mission forward. 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:

• HARMONi:
  Phase 3 study evaluating ivonescimab combined with chemotherapy vs placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a 3rd generation EGFR TKI.
• HARMONi-3:
  Phase 3 study evaluating ivonescimab combined with chemotherapy vs pembrolizumab combined with chemotherapy in first-line metastatic NSCLC.
• HARMONi-7:
  Phase 3 study evaluating ivonescimab monotherapy vs pembrolizumab monotherapy in first-line metastatic NSCLC.
• HARMONi-GI3:
  Phase 3 study evaluating ivonescimab in combination with chemotherapy vs bevacizumab plus chemotherapy in colorectal cancer (CRC).

Ivonescimab is an investigational therapy not presently approved by regulatory authorities other than China’s NMPA. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

Serves as the study-level biostatistician, including reviewing protocol, conducting sample size calculations, developing a statistical analysis plan (SAP), data presentation plan, and Data Monitoring Committee (DMC) charter, and reviewing study documents (e.g., CRFs, ADaM specifications, statistical outputs) for clinical trials in oncology. Partners with cross-functional team members to ensure accuracy/consistency of clinical data, 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 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, apply appropriate statistical methods, interpret study results, and collaborate with the clinical team to produce interim reports and final clinical study reports.
• Contribute to the preparation of manuscripts for publication with accurate statistical reporting of findings.
• Develop and implement new statistical methodologies to enhance study design and analysis.
• Review and analyze safety reporting, biomarker analyses, and other aspects of 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.
• Adhere to regulatory requirements of study conduct, statistical analysis principles, industry standards, and company SOPs.

• Ph.D. in Statistics, Biostatistics or equivalent with 6+ years in the biopharmaceutical industry required. MS with extensive industry and leadership experience (8+ years) may be considered.
• Strong proficiencies in software and tools 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.
• Ability to multi-task and manage time-sensitive, highly confidential documents.
• Effective communication of complex ideas in an easily understandable way.
• Work in a fast-paced, demanding and collaborative environment.

The pay range for this role is $245,000 to $307,000 annually. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and location. This may differ due to cost of labor differences by location. Total compensation may include bonus, stock, benefits and/or other variable compensation.

Summit does not accept referrals from employment businesses and/or agencies for vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring candidates.