Associate Director – Biostatistics
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Job Description
Associate Director of Biostatistics providing statistical leadership in clinical development programs at CG Oncology. Collaborating with clinical teams to support oncology drug development and regulatory strategy.
Responsibilities:
- 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.
Requirements:
- 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
Benefits:
- HIGHLY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
- 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
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