Responsibilities:
- Offer statistical input to protocol design
- Review protocol, Case Report errorform (CRF) and Data Validation Plan (DVP)
- Prepare Statistical Analysis Plan (SAP)
- Prepare for and participate in database release meeting
- SAS programming, statistical analyses and preparation of output according to SAP.
- Review Clinical Trial Report, presentation slides and scientific publications for statistical and scientific contents
- Ensure documentation for the trial in accordance to ICH GCP guidelines and SOPs
Requirements:
- Bachelor degree in scientific or biomedical errorarea, preferable major in statistics, master degree is desirable
- 2 years of biostatistician, SAS programming experience, working experience in clinical studies is desirable
- Data management experience preferred
- Knowledge and experience in designing and planning clinical trials
- High degree of skill in the resolution of SAS programming issues and sample size calculation softwares
- Fluent in written and spoken English
- Ability to plan and prioritize complex tasks and approach these in a flexible manner.
- Ability to work effectively as a good team member