Director, Biostatistics

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    "description": "<h2>Overview</h2>\n<p>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.</p>\n<p>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.</p>\n<h2>Responsibilities</h2>\n<p>Statistical Leadership</p>\n<ul>\n <li>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.</li>\n <li>Provide direct input into trial design, endpoint selection, sample size justification, interim analyses, and adaptive strategies, particularly for early‑stage development  </li>\n <li>Author, review, and approve:</li>\n <ul>\n  <li>Statistical sections of clinical protocols</li>\n  <li>Statistical Analysis Plans (SAPs)</li>\n  <li>Tables, listings, and figures (TLFs)</li>\n  <li>Clinical Study Reports (CSRs)</li>\n </ul>\n</ul>\n<p>CRO Oversight & Execution</p>\n<ul>\n <li>Serve as the primary statistical point of contact for CROs, providing close, day‑to‑day oversight of outsourced biostatistics and programming activities  </li>\n <li>Actively review CRO deliverables for scientific accuracy, consistency, and regulatory compliance, including datasets, analysis outputs, and reports </li>\n <li>Ensure CROs adhere to agreed‑upon timelines, quality standards, CDISC/CDASH conventions, and statistical methodologies </li>\n <li>Lead CRO selection, scope definition, and ongoing performance management for biostatistics and programming services </li>\n</ul>\n<p>Cross‑Functional & Regulatory Engagement</p>\n<ul>\n <li>Partner closely with Clinical Development to ensure statistical approaches align with program objectives and clinical strategy   Finish  </li>\n <li>Provide statistical expertise for data monitoring committees, interim analyses, and data review meetings</li>\n <li>Contribute directly to regulatory submissions, briefing documents, and responses to health authority questions  </li>\n <li>Represent biostatistics in cross‑functional development teams and external regulatory interactions as needed</li>\n</ul>\n<p>Operational Focus</p>\n<ul>\n <li>Ensure the timely production and accuracy of all statistical analyses and integrated reports across assigned studies</li>\n <li>Maintain consistency of statistical approaches across programs while remaining flexible to study‑specific needs</li>\n <li>Stay current on evolving statistical methodologies, regulatory expectations, and industry best practices relevant to oncology and inflammation trials</li>\n</ul>\n<p>Statistical Programming Oversight</p>\n<ul>\n <li> 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.</li>\n <li>Translate Statistical Analysis Plans (SAPs) into clear, actionable programming specifications and define data structure requirements for external CRO partners or internal teams.</li>\n <li>Ensure rigorous quality control (QC) and validation of analysis datasets and statistical outputs to meet FDA/EMA regulatory standards.\"</li>\n <li>Collaborate with data management and clinical teams to resolve data issues and ensure consistency between clinical databases and statistical outputs.</li>\n <li>Develop and implement efficient statistical programming workflows, macros, and best practices to improve productivity and compliance across multiple clinical trials</li>\n</ul>\n<h2>Qualifications</h2>\n<ul>\n <li>PhD in Biostatistics, Statistics, Mathematics, Computer Science, or related field </li>\n <li>15 +years of experience supporting clinical drug development, including Phase 1–Phase 3 trials and regulatory submissions </li>\n <li>Demonstrated experience working in CRO‑heavy models, with direct responsibility for reviewing and managing outsourced statistical work  </li>\n <li>Strong expertise in clinical trial statistics, regulatory standards (FDA, ICH), and industry best practices  </li>\n <li>Proficiency with SAS and other commonly used statistical software  </li>\n</ul>",
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