Hybrid in Chicago: Sr. Biostatistician (232408)

Life Sciences & Technology
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Job Description 

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.

Required Skills 

Statistical Analysis, SAS, Clinical Study Reports (CSR), Statistical Analysis Plan (SAP), FDA Submissions, Collaborative Communication

Hybrid in Chicago: Sr. Biostatistician (232408) 

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Northeast

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