·       Serves as  on-site expert for R&D China and works with regulatory, medical and  clinical teams to prepare CTAs and NDAs with a strong mindset of quality,  compliance, milestones, and regulatory approval

·          •Applies  statistical knowledge and experience to the design of clinical studies,  ensuring that study objectives can be met. This requires calculation of  sample size and power, as well as possible determination of appropriate  design assumptions from published literature.

·          • Prepares  relevant sections of protocols, especially those detailing the plans for data  analysis, and justification for the sample size. Reviews entire protocol for  consistency.

·          • Assists  in development and review of case report forms, ensuring data will be  collected efficiently and accurately.

·          •  Identifies potential threats to study credibility and validity, and works  with study team to prevent, track, and manage potential problems.

·          • Writes  the statistical analysis plan for the study and error-checking requirements  for the study data.

·          • Takes responsibility  for responding to relevant questions from regulators.

·          • Uses a  variety of statistical methods and software tools to analyze and display data  from clinical studies, appropriate for the kind of data collected. Required  assumptions must be tested.

·          •  Interprets clinical results and ensures data accuracy and consistency of  regulatory submissions, reports, and manuscripts.