Required skills Familiarize with innovative clinical study designs, complex analytical methods, and inferential statistics and be able to conduct mathematical and statistical simulations based on those advanced methodologies to support clinical trials; apply advanced knowledge and leverage hands on experience on data analyses utilizing mathematical and statistical programming software and languages such as SAS, R, Matlab, etc. to facilitate drug development processes in pharmaceutical industry; demonstrate extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, conduct and analysis of clinical trials, and regulatory submissions; provide oversight of statistical activities such as SDTMADaM standards, TFLs, etc. to ensure timeline and quality of analysis data and statistical outputs. Up to 10 travel required.
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