Director, Biostatistics

Role Summary

Director, Biostatistics to lead statistical strategy and execution across CG Oncology’s clinical programs, with an immediate focus on advancing our lead oncolytic immunotherapy candidate. This role supports efforts toward a Biologics License Application (BLA), approval, and commercialization. The Director will partner with internal teams and oversee biostatistical deliverables from external CROs, ensuring seamless execution from trial design through data interpretation, publication, and regulatory submission.

Responsibilities

• Serve as the lead biostatistician supporting CG Oncology’s development programs for the lead candidate.
• 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, SAPs, CRFs, and data management plans.
• Direct and validate statistical deliverables from external CROs and CG Data Management personnel, 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 improve 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, providing 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.

Skills

• Statistical leadership for clinical development programs
• Regulatory submission support (NDA/BLA) and regulatory compliance knowledge
• CDISC standards (SDTM/ADaM) familiarity
• Bayesian adaptive methods, predictive modeling, trial simulations
• Collaborative cross-functional partnership
• Strong communication of complex statistical concepts to non-statistical stakeholders

Education

• MS in Biostatistics, Statistics, or a closely related quantitative discipline

Additional Requirements

• Location: Remote