Director, Biostatistics

Responsibilities

• 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), and Clinical Study Reports (CSRs).
• 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.
• Partner closely with Clinical Development to ensure statistical approaches align with program objectives and clinical strategy.
• Contribute directly to data monitoring committees, interim analyses, and data review meetings.
• Represent biostatistics in cross-functional development teams and external regulatory interactions as needed.
• 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.
• 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.
• 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.
• Develop and implement efficient statistical programming workflows, macros, and best practices to improve productivity and compliance across multiple clinical trials.
• Collaborate with data management and clinical teams to resolve data issues and ensure consistency between clinical databases and statistical outputs.
• Implement and maintain robust quality assurance processes for statistical programming and reporting.

Requirements

• 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

Qualifications

• Expertise in statistical methods relevant to oncology and inflammatory disease trials
• Experience with regulatory submissions and briefing documents
• Ability to work effectively in a cross-functional team environment
• Strong communication and collaboration skills

Skills

• Statistical programming
• Data management
• Interdisciplinary collaboration
• Regulatory compliance

Benefits

N/A

Pay

N/A

Schedule

N/A