1. Develop and review the case report form (CRF).
2. Develop and review the database specification.
3. Develop and review the database structure on the database builder.
4. Develop and review the data validation specification.
5. Conduct the database validations including the user acceptance testing.
6. Develop and maintain the CRF library.
7. Develop and maintain the edit checks (ECS) library.
8. Develop and conduct the data review process and dummy data generation.
9. Oversee and coordinate clinical data integration activities as a DMPM.
10. Develop and update the templates of related processes.
11. Develop and manage the working process and standard operating procedures (SOPs).
12. Act as a mentor for the Associate Clinical Data Scientist I
13. Complete other tasks or assignments requested by the Supervisor.
1. Reads and analyzes protocol, statistical analysis plan, CRF and other trial design documents and discusses with other team members such with as biostatisticians and data managers.
2. Develops and debugs simple to complex SAS program in a timely manner
3. Implements statistical analysis plan, data preparation, and data manipulation into SAS programs and macros
4. Create analysis datasets, statistical tables, figures, and listing for clinical trial data.
5. Create CDISC standard datasets (SDTM and ADaM)
6. Participates in the validation of SAS programs and analysis datasets
7. Maintains documentation for SAS programs and validation results
8. Leads and coordinates the programming work for projects involving SAS programming if necessary
9. Coordinates timelines in orders to fulfill the needs of other departments