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

CG Oncology is seeking an experienced and driven Director, Biostatistics to lead statistical strategy and execution across our clinical programs, with an immediate focus on advancing our lead oncolytic immunotherapy candidate, Cretostimogene grenadenorepvec. This role is critical in supporting the company’s efforts toward a Biologics License Application (BLA), approval, and commercialization. Cretostimogene grenadenorepvec has received both Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) from the FDA, underscoring the need for rigorous, creative, and regulatory aligned biostatistical leadership. The Director will partner closely with internal Clinical Development, Clinical Operations, and Medical Affairs teams and oversee biostatistical deliverables from external CROs, ensuring seamless execution from trial design through data interpretation, publication, and regulatory submission.

Location: Remote

Essential Functions

• Serve as the lead biostatistician supporting CG Oncology’s development programs for Cretostimogene.
• Provide statistical leadership in the design, simulation, and interpretation of Phase I–III clinical trials with a focus on urologic oncology and immunotherapy.
• Develop and review key study documents including clinical trial protocols, statistical analysis plans (SAPs), case report forms (CRFs), and data management plans.
• Direct and validate statistical deliverables from external CROs and functional service providers, as well as CG Data Management personnel in ensuring alignment with regulatory expectations, CDISC standards (ADaM/SDTM), and ICH-GCP.
• Lead the development of statistical sections for regulatory documents including NDAs, briefing packages, and BLAs.
• Design and interpret interim analyses, final study reports, and integrated summaries of efficacy and safety.
• Apply Bayesian adaptive methodologies, predictive modeling, and operating characteristic simulations to inform trial progression and enhance efficiency.
• Collaborate with R&D, Clinical Development, and Clinical Operations to support biomarker integration, subgroup analyses, and model-informed drug development (MIDD).
• Ensure statistical rigor in publications, presentations, and Medical Affairs outputs.
• Contribute to CG Oncology’s evidence generation strategy, including real-world evidence (RWE) and post-marketing studies.
• Serve as a strategic partner to senior leadership, bringing data-driven insights into program decisions and portfolio planning.

Qualifications

• MS in Biostatistics, Statistics, or a closely related quantitative discipline.
• 6 to 10 years of biostatistics experience in biotech/pharma or CRO settings.
• Demonstrated success leading statistical strategy for Phase I–III oncology clinical trials.
• Direct experience contributing to regulatory submissions, including at least one significant role in BLA/NDA preparation or support.
• Prior experience with Breakthrough or Fast Track designated programs is a strong plus.
• Experience working with oncology, uro-oncology, immunotherapies, or oncolytic viruses highly preferred.
• Advanced programming skills in SAS and R; working knowledge of CDISC (SDTM, ADaM); experience with eCTD submissions preferred.

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 2025 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.