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Collaborate with clinical project team to establish project objectives and timelines for IVD/MD trials Providing statistical expertise to support study design, protocol development and data interpretation Writing of statistical analysis plans, statistical sections of trial protocols and synopses as well as contributions to other regulatory documents Prepare datasets and perform data analysis as well as programming of tables, listings and figures Close cooperation with data management during creation of data collection forms Performs quality check of datasets in cooperation with data management and identify outstanding data errors Work with clinical study teams to ensure the up-to-date and error free data are available at the time of analysis Create, document and maintain detailed data definition and inventory of all data and program Provide statistical analysis supp...