About the job
The Position
As the Director of Biostatistics at Maze Therapeutics, you will be pivotal in guiding the clinical advancement of our innovative therapeutic programs. This role involves close collaboration with teams in Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science, ensuring our clinical studies are methodologically sound, data-driven, and impactful.
You will be responsible for the biostatistical strategy and execution, overseeing the entire process from study design to regulatory submissions, seamlessly blending hands-on expertise with strategic oversight. Your role will include representing the Biostatistics function in clinical study teams, guiding the interpretation of intricate data, and managing CRO partnerships to guarantee the delivery of high-quality statistical outputs.
This position reports directly to the Vice President of Biometrics.
Your Impact
- Lead biostatistical efforts for clinical studies, offering expert insights on study design, endpoints, and statistical methodologies.
- Oversee the completion of all technical and operational statistical tasks for a portfolio of clinical trials, ensuring the development and review of complex and innovative statistical analysis plans (SAPs).
- Work collaboratively with cross-functional teams on protocol development, study design discussions, and data interpretation.
- Partner with Statistical Programming to develop and validate analyses for internal purposes, publications, and regulatory submissions.
- Supervise CRO execution of statistical tasks, ensuring adherence to timelines, quality standards, and analytical approaches.
- Represent the Biostatistics department in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparations, and responses to agency inquiries.
- Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA).
- Utilize advanced statistical techniques to analyze and interpret clinical, safety, biomarker, and exploratory data.
- Advise internal and external stakeholders on statistical methodologies, data integrity, model selection, and result interpretation.
- Lead the integration and analysis of diverse data sources to facilitate the delivery of special projects and statistical analysis plans for assigned products.
- Review and assess safety reports, biomarker analyses, and other elements of clinical trial monitoring.
- Enhance statistical software as needed by programming new techniques; stay updated on current and emerging trends in statistical analysis methodologies and tools.
- Provide biostatistical input into clinical development documentation and scientific publications.
