Overview
The Director of Biostatistics is a hands-on statistical leader responsible for the design, analysis, and interpretation of Phase 1-Phase 3 clinical trials with a primary focus on inflammation and oncology indications. This role combines scientific leadership with active execution and intensive CRO oversight, ensuring high-quality statistical deliverables across outsourced clinical studies. The Director will work closely with Clinical Development and external partners to drive trial design, analysis strategies, and regulatory-ready outputs while remaining directly involved in study-level statistical activities.
Responsibilities
Statistical Leadership
Lead and personally contribute to statistical strategy and execution for Phase 1-3 clinical studies, including first-in-human, dose-escalation, proof-of-concept, and registrational trials in oncology and inflammatory diseases.
Provide direct input into trial design, endpoint selection, sample size justification, interim analyses, and adaptive strategies, particularly for early-stage development
Author, review, and approve: Statistical sections of clinical protocols Statistical Analysis Plans (SAPs) Tables, listings, and figures (TLFs) Clinical Study Reports (CSRs)
CRO Oversight & Execution
Serve as the primary statistical point of contact for CROs, providing close, day-to-day oversight of outsourced biostatistics and programming activities
Actively review CRO deliverables for scientific accuracy, consistency, and regulatory compliance, including datasets, analysis outputs, and reports
Ensure CROs adhere to agreed-upon timelines, quality standards, CDISC/CDASH conventions, and statistical methodologies
Lead CRO selection, scope definition, and ongoing performance management for biostatistics and programming services
Cross-Functional & Regulatory Engagement
Partner closely with Clinical Development to ensure statistical approaches align with program objectives and clinical strategy
Finish
Provide statistical expertise for data monitoring committees, interim analyses, and data review meetings
Contribute directly to regulatory submissions, briefing documents, and responses to health authority questions
Represent biostatistics in cross-functional development teams and external regulatory interactions as needed
Operational Focus
Ensure the timely production and accuracy of all statistical analyses and integrated reports across assigned studies
Maintain consistency of statistical approaches across programs while remaining flexible to study-specific needs
Stay current on evolving statistical methodologies, regulatory expectations, and industry best practices relevant to oncology and inflammation trials
Statistical Programming Oversight
Direct and mentor statistical programmers to ensure accurate, timely, and compliant production of CDISC-compliant datasets (SDTM/ADaM), tables, listings, and figures (TLFs) for clinical study reports.
Translate Statistical Analysis Plans (SAPs) into clear, actionable programming specifications and define data structure requirements for external CRO partners or internal teams.
Ensure rigorous quality control (QC) and validation of analysis datasets and statistical outputs to meet FDA/EMA regulatory standards." Collaborate with data management and clinical teams to resolve data issues and ensure consistency between clinical databases and statistical outputs.
Develop and implement efficient statistical programming workflows, macros, and best practices to improve productivity and compliance across multiple clinical trials
Qualifications
PhD in Biostatistics, Statistics, Mathematics, Computer Science, or related field
15 +years of experience supporting clinical drug development, including Phase 1-Phase 3 trials and regulatory submissions
Demonstrated experience working in CRO-heavy models, with direct responsibility for reviewing and managing outsourced statistical work
Strong expertise in clinical trial statistics, regulatory standards (FDA, ICH), and industry best practices
Proficiency with SAS and other commonly used statistical software