Stat Programmer/Principal Programmer

该职位来源于猎聘 Main responsibilities:

• Annotate CRFs and review Protocol
• Work closely with Rave database Architect to help develop EDC screens
• Write programs to convert OD to OAD (SDTM-plus) datasets
• Process third party vendor data and edit checks
• Protocol Deviation checks – there are macros that are used in conjunction with additional code to generate protocol deviation checks.

Basically, they’re edit checks enveloped under a series of macros.

• Perform validation activities of OD to OAD process
• Process cut-off data using standard macros and the Tosca utilities/panels.
• Work with data manager to establish codelists and develop standard macros
• The setup is aimed at delivering quality data in a timely manner for data analysis and reporting in clinical trial Phase 1 -
• Stats uses the SDTM-plus datasets that the DM programmer generates.

Our job is to process all Rave data (i.e. OD) to OAD datasets. Also, all third party vendor data (that I’ve seen) is integrated into the Sdtm-plus datasets

• Incumbent supports study level implementation of medical standards and technical functionality in studies as defined
• Incumbent supports study level implementation of system functionality in close collaboration with Study Managers, Study Lead Monitors, Study Data Managers including DIS study support staff and
• Statistical analysts etc..
• Interact with

Bayer (DM Programmer), my Data Manager, Rave database designer, the Statistician, and third party vendors.

• Ensures that study data acquisition setup activities are tested and documented according to applicable SOPs and supports audits and inspections of the same.
• Perform validation on the OD to OAD conversion process.

Required Skills

• Bachelor or advanced degree in statistics, biological sciences, computer science or other equivalent discipline and experience.
• At least 3-5 years SAS programming experience in clinical research with emphasis in the development and support of the analysis of clinical data.
• Knowledge and experience with international clinical research and drug development.