Associate Director, Biostatistics

About the role
The Associate Director, Biostatistics provides statistical leadership and technical expertise across one or more clinical development programs. This individual is responsible for the design, analysis, interpretation, and reporting of clinical studies and contributes to development and regulatory strategies through close cross functional collaboration. The Associate Director will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Data Management, Statistical Programming, Translational Sciences, Medical Affairs, and external partners to support critical development and business decisions.

This role requires a strong understanding of oncology drug development, regulatory strategy, and statistical methodologies applicable to registration-enabling studies. Location: Remote

Essential Functions
Guide Study Design and Execution of Clinical Trials
Provide statistical leadership and oversight for Phase 1-3 clinical trials. Contribute to and lead statistical aspects of study design activities including endpoint selection, sample size determination, randomization strategies, interim analyses, and statistical methodologies. Partner with Clinical Development and Clinical Operations to ensure study objectives, statistical assumptions, and operational execution are aligned.

Review and provide input on protocols, protocol amendments, study conduct, and trial execution to ensure scientific rigor and regulatory acceptability. Support Data Monitoring Committees (DMCs), Safety Review Committees, and other governance bodies as needed. Author/Review Regulatory Documents and Support Regulatory Strategies
Lead or contribute to the development and review of SAPs, protocols, CSRs, and regulatory submission documents.

Support statistical contributions to regulatory interactions, including preparation for meetings with FDA and international health authorities. Contribute to regulatory strategy by ensuring statistical approaches align with applicable regulatory guidance and expectations. Support preparation of responses to regulatory questions, information requests, and health authority meetings.

Ensure statistical deliverables meet quality, compliance, and submission readiness standards. Data Interpretation and Support Decision Making
Interpret and communicate clinical trial results to cross-functional teams and functional leadership. Translate complex statistical findings into clear, actionable insights that inform development strategy and business decisions.

Contribute statistical input into benefit-risk assessments, program evaluations, and clinical development planning. Support publication strategies, scientific presentations, and external communications by ensuring accurate interpretation of statistical results. Present statistical analyses and recommendations to cross-functional teams and governance committees.

Process Improvements
Identify opportunities to enhance efficiency, quality, and consistency across biostatistical processes and deliverables. Contribute to the development and implementation of standards, templates, and best practices. Promote innovative statistical methodologies, data visualization approaches, and analytical tools.

Contribute to inspection readiness initiatives and continuous improvement of quality systems. Promote statistical integrity, reproducibility, and compliance with industry and regulatory standards. Oversee CROs and External Partners
Provide oversight and management of CRO statisticians, statistical programmers, and other external vendors.

Review and QC vendor deliverables to ensure quality, scientific accuracy, regulatory compliance, and adherence to timelines. Establish expectations, monitor performance, and proactively manage risks related to outsourced statistical activities. Serve as a key statistical representative for external partners and ensure alignment with program objectives.

Support vendor selection, budgeting, and resource planning activities as needed. Mentor Team Members
Provide technical guidance, coaching, and mentorship to statisticians and cross-functional team members. Foster a culture of collaboration, accountability, scientific excellence, and continuous learning.

Support talent development through training, knowledge sharing, and professional growth opportunities. Support departmental resource planning and knowledge-sharing initiatives. Serve as a role model for leadership, collaboration, and effective communication across the organization.

Qualifications

MS or PhD in Biostatistics or related field
8+ years of experience in pharmaceutical, biotechnology, or CRO industry
5+ years supporting oncology clinical development programs
Direct experience supporting regulatory submissions (BLA, NDA, MAA, or equivalent)
Experience interacting with FDA and/or global health authorities
Experience managing CROs and external statistical vendors
Demonstrated success leading cross-functional teams and influencing development strategy
Regulatory submission experience
Strong SAS/R expertise
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.