The Sr. /Principal Statistical Scientist will be aligned therapeutically with cross-functional Medical Affairs teams to provide statistical and analytical leadership in the development and execution of medical strategies, plans and projects. Like other team members in Biostatistics, this candidate will be responsible for the statistical integrity, adequacy and accuracy of prelaunch, launch and post-marketing clinical studies, as well as other investigations and assessments, including exploratory analyses. As such, this role will be a standing member of the assigned Medical Team, may also lead Biostatistics teams, and participate in other crossfunctional projects or working teams. Given the nature of their positions, statistical scientists also work closely with their counterparts in Pharmaceutical Development and potentially Pharmaceutical Research and Early Development to align clinical data and statistics across varying drug development phases. Where assigned, this candidate will also act as Medical Affairs representatives in related review and decision-making forums or committees, including, where applicable, representing Biostatistics input and data in health authority meetings, presentations and communications.
A PhD with four years' experience, or a Master's Degree and seven years' experience in statistics/biostatistics is required (PhD preferred). Four or more years' clinical trial experience is also required (experience should include in clinical trials through at least two complete trials/registries or comprehensive product exploratory ana lysis projects). In-depth knowledge of ICH-GCP and other relevant standards and guidelines and a comprehensive understanding of theoretical and applied statistics are desired as well. In-depth knowledge of Phase IV/postmarketing drug development is also required (knowledge of or experience with Phase I - III drug development is preferred). Extensive experience in the principles and techniques of data analysis, interpretation and clinical relevance and relevant therapeutic area (respiratory and immunology) knowledge is a plus.
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