Principal Statistical Analyst

About the Company

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. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people. Summit is currently conducting multiple global Phase 3 clinical studies in oncology, including:

• Non-small Cell Lung Cancer (NSCLC):
  • 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.
• Colorectal Cancer (CRC):
  • HARMONi-GI3: Phase 3 study evaluating ivonescimab in combination with chemotherapy vs. 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, with additional offices in California, New Jersey, the UK, and Ireland.

About the Role

The Principal Statistical Analyst will support and/or lead statistical programming activities for clinical trial data collection, analysis, reporting, and visualization for all Summit drugs. Responsibilities include producing, reviewing, and optimizing program code, managing project timelines, ensuring deliverable quality, and maintaining compliance with procedures. The role involves collaboration with statisticians, data management, clinicians, medical writers, medical affairs, and regulatory teams.

Responsibilities

• Implement statistical analysis of clinical trial data in collaboration with Biostatistics, including development and validation of ADaM specifications, datasets, and TLFs to support regulatory, medical affairs, and market access needs.
• Consolidate heterogeneous data sources (e.g., clinical study databases, external databases, real-world data) to prepare analysis-ready datasets for projects or study deliverables.
• Implement CDISC SDTM and ADaM specification datasets in partnership with Biostatisticians.
• Perform compliance checks and resolve issues during the programming process.
• Create documentation for regulatory filings, including reviewers' guides and data definition documents, ensuring compliance with FDA guidelines.
• Perform data and statistical analysis, generating safety and efficacy tables, figures, and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
• Review Data Management Plans, Data Monitoring Plans, and edit check specifications.
• Implement data monitoring listings and SAS edit checks to support team data monitoring.
• Evaluate project scope or ad hoc requests for resource allocation, timeline planning, and stakeholder delivery.
• Validate the work of other programmers/analysts at CROs or in-house to ensure appropriate validation processes.
• Create, debug, validate, or maintain company-level macros to streamline repetitive operations and increase programming efficiency.
• Act as a liaison between statistical programming and other functional teams within study teams.
• Lead or participate in the development of Standard Operating Procedures (SOPs).
• Improve the efficiency and quality of existing workflows and mentor Statistical Programmers and Analysts.
• Perform additional duties as assigned.

Requirements

• Bachelor’s or Master’s degree in Biostatistics, Statistics, Computer Science, or a related field.
• Minimum of 7+ years of pharmaceutical/biotech programming experience; experience with oncology trials preferred.
• Solid knowledge of CDISC standards, including SDTM and ADaM.
• Hands-on experience with programming support for data monitoring and data cleaning/query processes.
• Familiarity with clinical data coding dictionaries (MedDRA and WHODD).
• High degree of technical competence and strong oral/written communication skills.
• Proficiency in SAS programming and macro development.
• Working knowledge of current regulatory requirements and ICH guidance, with a deep understanding of clinical trial compliance.
• Pharmaceutical experience with clinical trials, including familiarity with regulatory expectations (e.g., FDA, EMEA).
• Experience with NDA/BLA or other regulatory filings, including ISS or ISE.
• Ability to work under pressure, manage shifting priorities, and lead or collaborate effectively within a team.
• Strong project management skills, including planning, execution, resource allocation, and timeline management.
• Ability to proactively identify and address project uncertainties to minimize risk.
• Strong problem-solving and analytical skills.
• Fluency in 2+ relevant programming languages (e.g., R, Python) is a plus.

Pay

Pay Transparency: $10 - $20 USD per hour. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.