Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research - You will contribute to statistical activities related to global clinical trials and work closely with international teams of , and , including the role of biostatistics project lead * Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis * Expert knowledge and understanding of the SAS programming * Expert knowledge and understanding of CDISC ADaM standard * Expert knowledge and understanding of adaptive designs * Expert knowledge and understanding of sample size calculation * Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH) * Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, ...
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