Responsibilities:
- Offer statistical input to protocol design
- Review protocol, Case Report errorform (CRF) and Data Validation Plan (DVP)
- Prepare for and participate in database release meeting
- CRF tracking, database development, data review and processing, dictionary coding, edit checking, database auditing, statistical analysis and programming.
- Ensure documentation for the trial in accordance to ICH GCP guidelines and SOPs
Requirements:
- MS or PHD in Life Biostatistics, Statistics, Mathematics, Applied Mathematics, Computer Programming or related field
- 2 years of Data Manager, SAS programming experience, working experience in clinical studies is desirable
- High degree of skill in the resolution of SAS programming issues and sample size calculation software, Mastering EPI Data/Oracle/SQL is favorable
- 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