ObjectiveReporting to the Chief Medical Officer, the Senior Director, Biostatistics, provides strategic and operational leadership for an established biostatistics function supporting the design, analysis, evaluation, and reporting of clinical trials. The role is accountable for overseeing end-to-end clinical data workflows, ensuring the high-quality evaluation of clinical data, and maintaining robust systems and processes to support efficient trial execution. The Senior Director will further develop and mentor biostatistics staff to ensure the continued effectiveness and scalability of this critical function.Essential FunctionsStudy Design – In collaboration with cross-functional team members, provide statistical leadership in the development and evaluation of study designs and methodologies to address clinical hypotheses. Responsibilities may include participation in early research design for new programs as well as the refinement and support of statistical approaches for studies already in progress, including late-stage clinical trials.Data Management – Partner with clinical operations, data management, and statistical programming teams to design, develop, and maintain fit-for-purpose clinical databases. Oversee and ensure robust data integrity controls, including reviewing edit checks and validation logic, defining analyzable and high-quality data requirements, and ongoing data quality monitoring. Establish and maintain efficient data archival systems suitable for multi-center and collaborative studies, and ensure thorough documentation of all data programming, validation, and archival processes.Data Analysis – Serve as a statistical advisor to clinical development leadership to determine appropriate analytical methodologies. Lead and/or oversee statistical programming and analysis activities across multiple research studies, utilizing a range of statistical models. Direct the creation of analysis datasets, data summaries, and statistical reports, primarily using SAS. Develop statistical analysis plans (SAPs) based on study protocols and define tables, listings, and figures (TLF) shells in accordance with the SAP. Author and review statistical sections of clinical documents, including study synopses, protocols, and clinical study reports. Evaluate the appropriateness of final statistical models and outputs, perform quality control and validation of work produced by statisticians and statistical programmers, and document methods and results through formal memoranda and reports. Provide ongoing statistical guidance for active and planned clinical studies. Manage biostatistics programming vendor to ensure timely, high-quality, and compliant statistical deliverables.General Support – Provide expert statistical review, validation, and consultation for internal and external projects. Communicate findings clearly to stakeholders and maintain complete study archives, including datasets and programming documentation. Contribute to the development, maintenance, and continuous improvement of internal guidelines and Standard Operating Procedures (SOPs). Conduct statistical simulations to evaluate innovative or novel clinical trial designs. Prepare and present project updates for routine status meetings and maintain current knowledge of statistical methodologies, regulatory expectations, and industry best practices.Statistical Reporting – Contribute to the preparation and review of clinical trial deliverables, including clinical study reports, internal reports, regulatory-supporting documentation, academic publications, and scientific presentations for national and international meetings.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below
