Associate Director, Biostatistics

CG Oncology

2h•$205,000 - $215,000•Remote

About The Position

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.

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

Responsibilities

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.
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.
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.
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.
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.
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.