Principal Biostatistician

The Principal Biostatistician is responsible for the design, analysis, and/or interpretation of clinical studies as a lead (or contributing team member) for clinical studies. In this role, the Principal Biostatistician will be part of a collaborative team that works with the sponsor, PM, clinical team, data managers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies). The Principal Biostatistician is responsible for (or participates in) the creation, review, maintenance, and oversight of all contracted statistical output and activities. These responsibilities may include, but are not limited to, relevant sections of the clinical protocol, the statistical analysis plan, data/safety review meetings, content development specifications, and review (or input into) relevant sections of summary reports. ROLE AND RESPONSIBILITIES Maintains responsibility for all assigned duties within a clinical study, this may include: Act as the study lead for multiple studies, clinical programs, and/or large/complex studies with responsibility for all biostatistics related activities. Support the review and development of clinical programs; may contribute to complex methods and analysis sections of protocols as well as support the review of design; able to provide feedback regarding issues or improvements to initial proposed designs. May involve oversight of the statistical programming activities. Ensuring that work is performed on time. Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality. Provide review and oversight to statistical output created by other members of the biostatistics department Review protocols, synopses, and other statistical documents for a study and provide feedback and consult. Research, or otherwise support, trial design and consultative activities Review relevant content from other functional areas (e.g., Case R