Description
Accomplishments * Complete more than 100 studies including phase I to phase IV. * In charge of 20 phase I and 4 phase III study NDA submission tasks to ensure high quality deliverables that comply regulatory electronic submission guidance * Preparation of statistical analysis plans including mock up tables * Application of statistical section of clinical trial reports * Review of protocols/case report forms/statistical analysis plans/clinical trial reports * Have thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development
Accomplishments
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