Only freelancers located in the U.S. may apply.U.S. located freelancers only
Our company has developed an ELISA test for bladder cancer and is planning a submission to the FDA for Premarket Approval. We currently need a statistical plan to use a collection of patient specimens to establish ELISA assay cutoff values, to perform assay validation, and determine analyte stability. The plan needs to be prepared and presented to the FDA by July 26, 2018.
• Prepare statistical analysis plans, develop table shells and graphs for proposals to FDA for in vitro device/diagnostic test submission.
• Analyze previous biology/clinical cancer study results and provide statistical input for continuing study design and study reports.
• MS or PhD in statistics or biostatistics.
• Experience with FDA submissions for in vitro devices and/or diagnostic tests.
• Experience working with biology and product R&D teams.
• Good interpersonal, communication, writing and organizational skills.
• Knowledge of statistical regulatory requirements is a plus.
• Knowledge of oncology is a plus.
Hours to be determined
Less than 1 month< 1 monthProject LengthDuration
I am looking for a mix of experience and value