The Principal Biostatistician is responsible for the design, analysis, and/or interpretation of clinical studies as a lead (or contributing team members) 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 mangers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies).

The 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