Associate Director, Biostatistics

The Associate Director, Biostatistics role will be responsible for overseeing statistical activities for multiple clinical studies and/or a clinical program, participating study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables. This individual will participate in departmental and cross functional technology development and process improvement initiatives. The responsibilities include but are not limited to serving as a lead statistician and managing statistical efforts for multiple clinical studies. Contributing to clinical protocol development, including authoring of the section on statistical methods. Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings. Reviewing CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses. Providing statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents. Working with statistical programmers or CROs to generate tables, figures and listings. Supporting ongoing safety review and DMC review of the clinical development program/study teams. Performing ad hoc and exploratory statistical analyses as needed. Contributing to clinical study reports, including authoring of statistical sections and interpretation of the study results. Supporting regulatory submissions as needed. Supporting the preparation of publications, including manuscripts, posters and oral presentations. Accountable for the performance and results at a study level. Ensuring the implementation of biostatistics decisions and best practices. Providing oversight of CROs for outsourced statistical activities and QC key results generated by CROs.