We are currently hiring a Biostatistician to join our FSP Team! This individual will provide statistical support for projects in the Vaccines Therapeutic Area. The successful candidate will collaborate and work closely with project / study teams and provide statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries.

• Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in supporting publication projects and regulatory query responses.
• Develop statistical analysis plans, mock-up tables, quality check plans.
• Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by programmers.
• Lead multiple project teams by applying project management skills, statistical and programming techniques to prepare, execute, report, and document of high-quality statistical analysis per statistical analysis plans.
• Conduct peer review of project related work performed by other statisticians, maintain compliance with the latest regulatory requirements, maintain project documentation and files according to departmental policy.
• Communicate competently and independently with client to coordinate the statistical and programming considerations of the project.
• Demonstrate strong understanding of ICH guidelines and clinical trial design, as applicable to statistics.