Director, Biostatistics

<h3>The Position</h3> <p>As the Director, Biostatistics, you will play an important role in shaping and supporting the clinical development of Maze’s therapeutic programs. You will partner closely with Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science to ensure our clinical studies are robust, data-driven, and impactful.</p> <p>In this role, you’ll oversee biostatistical strategy and execution, from study design through regulatory submissions, balancing hands-on expertise with strategic leadership. You will also represent Biostatistics on clinical study teams, guide interpretation of complex data, and oversee CRO partners to ensure high-quality statistical deliverables.</p> <p>The position will report to the Vice President, Biometrics.</p> <h3>The Impact You’ll Have</h3> <ul> <li>Serve as the biostatistics lead for clinical studies, providing expert input on study design, endpoints, and statistical strategy</li> <li>Oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials. Ensure development and review of statistical analysis plans (SAPs), including complex and innovative methodologies</li> <li>Collaborate with cross-functional partners in protocol development, study design discussions, and data interpretation</li> <li>Partner with Statistical Programming to generate and validate analyses for internal use, publications, and regulatory submissions</li> <li>Oversee CRO execution of statistical tasks: managing timelines, quality, and analytical approaches</li> <li>Represent biostatistics in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparation, and responses to agency questions</li> <li>Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA)</li> <li>Apply advanced statistical techniques to explore, analyze, and interpret clinical, safety, biomarker, and exploratory data</li> <li>Advise internal and external partners on statistical approaches, data reliability, model selection, and interpretation of results</li> <li>Lead the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products</li> <li>Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring</li> <li>Develop enhancements to statistical software, as appropriate, by programming new techniques; maintain knowledge of current and emerging trends in statistical analysis methodologies and tools</li> <li>Provide biostatistical input into clinical development documentation, scientif