Sep 2022 - Present
I. Data Management
- Design case report forms (CRFs)
- Develop CRF completion guidelines (CCG)
- Develop data validation plan (DVP)
- Build data cleaning specification
1. Develop Edit Check
2. Logic Check Specifications
3. Validated clinical data by SAS program
- Build up electronic data capture (EDC)
- Develop datasets by SDTM rules
- Conduct reconciliation of SAEs
- Clean general queries
- Maintain clinical study related documents
- Coordinate with cross-function departments for study issues
- Reviewed cross-function documents (e.g. protocol etc.)
II. Statistical Programmer
- Implement data manipulation into SAS programs and macros independently
- Develop statistical analysis plan
- Create data listings, statistical tables, and figures for clinical trial data
- Maintain documents of SAS programs and validation results
- Coordinate with cross-function departments for study issues