Senior Principal Programmer

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

The Senior Principal Programmer provides strategic and technical leadership for statistical programming activities across clinical development programs. This role is responsible for the development and delivery of high-quality, submission-ready datasets, analyses, and programming deliverables that support regulatory submissions and critical business decisions. The Senior Principal Programmer serves as a subject matter expert in CDISC standards, regulatory requirements, and programming best practices, while partnering cross-functionally to drive operational excellence, innovation, and inspection readiness across the development portfolio.

Location: Remote

Essential Functions

• Lead Statistical Programming Strategy and Execution
• • Provide technical leadership for statistical programming activities across multiple clinical development programs.
  • Lead the development, validation, and maintenance of SDTM and ADaM in accordance with CDISC standards and regulatory requirements.
  • Oversee creation and maintenance of specifications, Define.xml packages, and submission-ready deliverables.
  • Ensure programming deliverables support study objectives, statistical analyses, and regulatory submission requirements.
  • Serve as the programming subject matter expert for complex analyses, integrated summaries, and submission activities.
• Author, Review, and Validate Programming Deliverables
• • Lead the design, development, validation, and documentation of statistical programs supporting clinical study reporting and regulatory submissions.
  • Develop and review analysis datasets, tables, listings, figures (TLFs), patient profiles, and ad hoc analyses.
  • Ensure programming deliverables meet quality, traceability, reproducibility, and regulatory compliance standards.
  • Establish and maintain programming specifications, validation plans, and quality control procedures.
  • Support inspection readiness and audit activities through comprehensive documentation and traceability.
• Ensure Compliance with Industry and Regulatory Standards
• • Provide expertise in FDA, EMA, ICH, CDISC, and other applicable regulatory requirements related to clinical data standards and submissions.
  • Lead implementation and governance of SDTM, ADaM, and Define.xml standards across development programs.
  • Serve as a technical resource during regulatory submissions, inspections, and health authority interactions.
  • Evaluate evolving industry standards and regulatory guidance and implement best practices within the organization.
  • Support preparation and review of electronic submission packages and associated datasets.
• Drive Programming Innovation and Process Improvements
• • Lead development of departmental programming standards, macros, utilities, and reusable tools that improve efficiency and consistency.
  • Identify opportunities to automate workflows, improve data quality, and enhance operational scalability.
  • Drive continuous improvement initiatives across statistical programming processes and systems.
  • Evaluate and implement emerging technologies and programming methodologies to support clinical development objectives.
  • Champion programming excellence, reproducibility, and inspection readiness across the organization.
• Oversee CROs and External Partners
• • Provide strategic oversight of CRO statistical programming activities and external programming resources.