Senior Principal Programmer

About CG Oncology, Inc. A re 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. Review vendor deliverables for quality, consistency, regulatory compliance, and adherence to timelines. Establish programming expectations, standards, and governance processes with external partners. Monitor vendor performance and proactively identify and mitigate risks to program deliverables. Serve as the primary programming representative for outsourced activities and cross-functional collaborations. Mentor and Develop Team Members Provide technical mentorship and guidance to programmers across all levels of experience. Lead training initiatives related to CDISC standards, programming methodologies, validation practices, and submission requirements. Foster a culture of continuous learning, collaboration, innovation, and quality. Support departmental resource planning, talent development, and succession planning activities. Serve as a recognized technical leader and trusted advisor across Clinical Development, Biostatistics, Data Management, and Regulatory Affairs. Qualifications BS/MS in Computer Science, Statistics, Biostatistics, Mathematics, or related field 10+ years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry 5+ years leading complex programming activities across multiple clinical programs Extensive experience supporting NDA, BLA, MAA, or equivalent regulatory submissions Deep expertise in CDISC SDTM, ADaM, and Define.xml standards Advanced SAS programming expertise; experience with R and modern analytics platforms preferred Experience overseeing CROs and global programming teams Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid. Total Rewards CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer. HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWS ANNUAL PERFORMANCE BONUSES EQUITY SPECIAL RECOGNITION Well-Being Benefits In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce.  These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well-Being Benefits eligibility begins the 1st of the month after hire.  While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered. FULLY REMOTE WORK ENVIRONMENT REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off HOLIDAYS –In 2026 we will observe 14 holidays RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More CG Oncology is an Equal Opportunity Employer : All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.