Director of Biostatistics
Redwood City , CA /
Full Time Employee (FTE)
The Director of Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Independently provides strategic statistical input to drug development planning, including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions, and follow up. The Director is accountable for the production of biostatistics deliverables by providing oversight of the work performed by CROs, managing external (and/or internal) biostatistics and statistical programming resources and performing work themselves. The Director of Biostatistics coordinates with other functional groups to ensure timeliness and quality of project deliverables.
- Provide statistical expertise to all drug development programs as a Subject Matter Expert in Biostatistics and statistical leadership in the design of clinical development plans.
- Be the statistical leader and project manager accountable for all Biometrics deliverables for assigned product(s).
- Be a thought leader/expert in Oncology statistics, showing leadership/be the point of reference in statistical methods, regulatory guidelines (ICH, FDA, EMA, PMDA, CFDA, etc.)), program strategies, clinical development planning and study designs in multiple Oncology indications.
- Be a core member of the clinical team or the project team as representative for the Biostatistics and Programming functions to ensure coordination and alignment across Biometrics functions on program strategies and deliverables.
- Ensure the quality of statistical input, show ability to integrate expertise across Biostatistics components (e.g., Clinical Pharmacology (CP), Companion Diagnostics (CDx), Clinical Biomarker Statistics, Full Development Biostatistics, as well as from external statistical experts) into the assigned programs.
- Accountable for production of the following study-related deliverables: appropriate sections of study protocols, study related charters, case report forms, statistical analysis plans, data unblinding plan, data analyses, manuscripts, and sections of clinical study reports and other registration documents.
- Accountable for team’s statistical support aspects of assigned therapeutic areas including experimental design, protocol development, sample size estimation, statistical analysis plan development, patient randomization, case report form design, statistical analyses, and presentation of data.
- Directs and conducts statistical analyses and interprets results of analyses for assigned studies
- Ensure the team maintain consistent analytical approaches and reporting formats within and across studies.
- Accountable for the accuracy and completeness of statistical analyses conducted for assigned projects.
- Establishes and maintains effective working relationships with vendors and project teams, including data management, statistical programming, clinical research, and corporate partners.
- Provides statistical input for regulatory submissions; responds to statistical questions raised by regulatory agencies and institutional review boards.
- Manages operationally and functionally and supervises external statisticians on the team (as assigned).
Education and Experience Requirements
- Ph.D. in Biostatistics, Statistics or closely related discipline, with at least ten years of experience in the support of clinical studies in a pharmaceutical or biotech industry setting.
- Strong track record of developing/establishing statistical excellence and leading scientific improvement/change initiatives
- Expert knowledge in drug development process in Oncology, guidelines and submissions
- Proficient in the management and statistical analysis of data obtained from clinical trials and ability to translate clinical study designs into statistical practice.
- Comprehensive knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS, are a must.
- Experience with protocol development, clinical study reporting, ISS/ISE requirements, and regulatory submissions in paper and electronic format is essential.
- Demonstrated ability to have managed a successful team as well as functional/multi-functional teams and/or initiatives.
- Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Equal Employment Opportunity
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.