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Serve as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting. Develop individual protocols and data analysis plans and determine appropriate statistical methodology for data analysis. Participate in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. Collaborate with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements. Evaluate appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. Analyze data and interpret results from clinical trials to meet objectives of the study protocol. Independently apply and implement basic and complex techniques to these analyses. Prepare oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators. Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. Be responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies. Participate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies. Be involved in research activities for innovative statistical methods and applications in clinical trial development.
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Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree

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