Principal Statistical Analyst

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. 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.

• 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.

• 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.

The Principal Statistical Analyst will be responsible for supporting and/or leading the statistical programming activities for clinical trial data collection, analysis, reporting, visualization on all Summit drugs. Produce, review program codes and suggest alternative solutions that may be efficient. Allocate resources for project, manage project timeline, control quality of deliverables and ensure compliance of procedure. Interact with statisticians, data management, clinicians, medical writers, medical affairs personnel, and other members of Summit regulatory.

• Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Consolidate heterogeneous data source (e.g. clinical study databases, external databases, real world data) to prepare analysis‑ready datasets supporting a particular project, study deliverable.
• Work closely with Biostatistician to implement CDISC SDTM and ADAM specification datasets.
• Perform compliance check and resolve any compliance issue during the process.
• Create documentation for regulatory filings including reviewers guides and data definition documents and ensure compliance per FDA guideline.
• Perform data analysis, statistical analysis, generate safety and efficacy tables, figures and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/OD.
• Review Data Management Plan, Data monitoring plan and edit check specification.
• Implement data monitoring listings and SAS edit check to support team data monitoring.
• Evaluate scope of work for project or ad hoc requests on resource allocation, timeline buildup, and become the stakeholder on delivery.
• Validate work of other programmer/analysts at CRO or in‑house to ensure appropriate validation process.
• Create, debug, validate or maintain company level macros that streamline repetitive operations to increase programming efficiency.
• Act as a liaison in study team between statistical programming, and other functional teams as needed.
• Leads or participates in the development of standard operating procedures (SOP).
• Work on improving the efficiency and quality of existing workflows and mentors Statistical Programmers and Statistical analysts.
• Utilize R and…