Our client is seeking a Senior Biostatistician with significant FDA interaction experience and a background with In Vitro Diagnostics. This project will be a full time position with ongoing submission activities that will require strategic and tactical guidance. The candidate will provide input into protocols, develop and review statistical analysis plans and author/co-author reports with statistical content used to support the performance of new and/or modified products. The candidate must also be well versed communicating with and addressing requests received from the FDA in response to statistical aspects of study designs and analyses. The ideal candidate will have a minimum of 6+ years experience as a Biostatistician as well as 2+ years working on submissions and demonstrable knowledge communicating with the FDA. Soft skills are critical in this role as this candidate will be interfacing with a team of 20 and will sit in on FDA meetings.
Statistical Analysis, SAS, Clinical Study Reports (CSR), Statistical Analysis Plan (SAP), FDA Submissions, Collaborative Communication
Hybrid in Chicago: Sr. Biostatistician (232408)