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POST DATE 9/17/2016
END DATE 10/18/2016
Fresenius Kabi USA, LLC
Lake Zurich, IL
JOB DESCRIPTIONWe currently have an opportunity for a Biostatistician to join our Medical Devices R&D Department. This position will participate in the review of statistical documentation for clinical studies and for generating statistical deliverables per statistical analysis plans and other statistics documentation for clinical protocols.
Assist with providing statistical input for clinical protocols including Case Report Form (CRF) development and the design of mock output (TLGs).
Participate in the review of statistical analysis plans and other statistical documentation for clinical protocols based on study specific documents and sound statistical methodology.
Develop and maintain statistical programs and specifications used in creating analysis datasets and TLGs for clinical protocols.
Participate in verifying the conformance of data system design, utilization, and maintenance applicable to clinical protocols to applicable regulatory guidelines and standard operating procedures.
Provide statistical support for meetings with regulatory bodies and clinical project managers.
Assist with providing statistical support for non-clinical protocols including analysis dataset production and verification and statistical analysis.
Participate in the review of standard operating procedures, systems and conventions for the biostatistics area.
Fresenius Kabi offers an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match.