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This position will serve s the Medical Affairs biostatistician for the Thrombosis therapeutic area, and will ensure the timely and accurate completion of all statistical aspects of assigned clinical trials, integrated summaries and databases. Responsibilities: · In this role, you will serve as the project biostatistician for assigned Phase IIIB and IV studies. · You will collaborate with colleagues to ensure the acceptance of statistical design and analyses. · You will guarantee the accuracy of completed statistical analyses in clinical study reports, and interact with study team members and CROs to ensure deliverable timelines. · In this role, you will establish study design consistency, parameter algorithms, calculations and reporting formats. · You will make certain that study design, protocol preparation and statistical analysis methodologies meet project objectives and are in compliance. Additionally, you will ensure that conclusions based on post-hoc analyses are scientifically sound. · MS in Statistics, Biostatistics or Mathematics and at least 10 years of pharmaceutical industry experience OR a PhD in Statistics, Biostatistics or Mathematics and at least 8 years of pharmaceutical industry experience. · Full knowledge of advanced statistical analytical methods, clinical trial research, regulatory requirements, programming skills, and statistical software is required. · You must have demonstrated competency in SAS, as well as in analyzing clinical trial data. · Comprehensive project management, problem solving and prioritization skills are a must. · It is essential that you have prior experience managing CROs and external vendors. Submit Your Resume View All Jobs |
