Job Description:Position will design, develop and evaluate the technical and statistical infrastructure for the conduct and evaluation of clinical trials, including the coordination of all related areas and activities; improve processes, protocols, and Statistical Analysis Plans (SAPs); lead team in experimental design, protocol development, SAPs, and analysis to meet project objectives; create statistical analysis of clinical study reports, NDAs, INDs, and annual reports; serve as contributing member on critical project teams with Clinical Data Managers, Statistical Programmers and other MDG management responsible for meeting study objectives; determine best methods and techniques for complex analysis design; provide estimates of project resource requirements and timelines; conduct briefings and participate in technical and regulatory meetings with relevant representatives.
Qualification:The position requires a Ph.D. (or foreign equivalent) in Biostatistics, Statistics, or a related field plus one (1) year of experience in the job offered or in a related position. Alternatively, employer will accept a Master's degree (or foreign equivalent) in Biostatistics, Statistics, or a related field plus three (3) years of experience in the job offered or in a related position. Experience must include demonstrable knowledge of the following: Demonstrable experience leading statistical activities, managing study timeline and resources, and coordinating study activities with other functions; Demonstrable knowledge of clinical trials; Demonstrable experience with R language commonly used in clinical trial design and data analysis; Demonstrable experience with SAS language, procedures, and options commonly used in clinical trial reporting including BASE SAS and SAS/STAT; demonstrable experience with CDISC SDTM and ADaM models and conducting statistical analyses using SDTM/ADaM; demonstrable experience designing and conducting statistical simulations to address key strategic questions in clinical trials; demonstrable strong independent statistical research capacity including literature review, authoring peer-reviewed statistical and/or medical papers.
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