Economics Skilled in Statistical/Mathematical analysis
Coursework in Statistics and Mathematics
• Solid knowledge of SAS and familiarity with other statistical software packages.
• Participation in randomization development and validation process.
• Preparation of statistical analysis plans including mock up tables.
• Application of statistical methods and analysis of clinical study data.
• Preparation 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. Have the ability to identify, evaluate and implement as needed innovative statistical methods to provide added value to the company drug development process.
• In charge of 2 phase I and 2 phase III studies NDA submission tasks to ensure high quality deliverables that comply with regulatory electronic submission guidance:
Fluent in English, Mandarin
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