Biometrics · Bangalore, Karnataka
Brief Position Description:
The core responsibility for this position is as a member of the Data Management SAS department at Novotech. The Clinical Data Programmer-SAS Trainee (CDP-ST) will be responsible for performing SAS programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP).
Minimum Qualifications & Experience:
Graduate in Information Technology or Pharmacy or Clinical Research or life science related field or similar. Base SAS Certified with good understanding of Clinical Research terminologies. Awareness about different electronic data capture tools and metadata would be an added advantage.
- The CDP-ST will be responsible for SAS programming activities on different projects across different EDC applications in accordance with Novotech standards.
- Perform programming and QC of SAS programs for data listings or reconciliation listings or patient profiles or any other tables/graphs as per specifications for the Data Management group.
- May assist in monthly/weekly listings run as per the study team’s need for a project. This will also include alpha testing before releasing.
- Perform data mapping/reconciliation specifications and programming per the for the respective project. This will also include alpha testing before releasing.
- Performs status report setup and programming per the status report specifications for a project. This will also include alpha testing before releasing.
- The CDP-ST may be requested to design eCRFs and edit checks after necessary training for the respective EDC tools and provide technical support on projects
- The CDP-ST may be requested to provide some trouble shooting and problem solving related to programming on project.
- Perform external data entry loads, i.e. labs, ECGs etc., as needed.
- Support the Project/Programming Lead on a project on tasks as needed
- Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices.
- Support in the validation of electronic systems, software and programs implemented in accordance with current regulatory requirements.