Principal Biostatistician

Job DescriptionThe 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 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.* Serve as a lead statistician for multiple studies, clinical programs, integrations, submissions, adaptive designs, and other complex studies.* Provide review and oversight to statistical output created by other members of the biostatistics department.* Provide consultative support to sponsors and/or internal teams regarding topics of study design, exploratory analyses, statistical methods, and other relevant topics.* Represent sponsors in regulatory meetings.* Present relevant statistical output and findings to Safety Review Committees (and other similar bodies).* Represent biostatistics in qualification audits, study audits, and other pre-trial assessment activities.* Represent the function in bid defences and other sales related activities such as review of RFP content; including input to the budget, suggestions related to study design, and other contributions to the opportunity strategy.* Lead initiatives and process improvement activities on behalf of management.* Supports the head of Biostatistics (and as needed, Head of Biometrics) on topics related to statistical issues, process improvement, industry trends, and other relevant topics.