DM/STDM Programmer
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Job Description
DM/STDM Programmer managing SDTM data and ensuring quality for clinical trial submissions. Collaborating with Sponsors and CRO partners while working remotely across Europe or South Africa.
Responsibilities:
- Review and programming of SDTM deliveries
- Build and review SDTM submission packages
- Ensure quality and completeness of SDTM format data
- Collaborate with Sponsor colleagues and CRO Partners to review SDTM
- In collaboration with Study Data Leads ensure the planning for data receipt and its oversight throughout the duration of assigned clinical trials
- Program reports and contribute to the standardization of process and reports used for data review and analysis for external partners/vendors and internal teams
- Complete formal and ad-hoc analyses and oversight of SDTM data
- Review of critical document/deliverable (SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of DE dataset
- Program either SDTM SAS PRD or SAS QC of some SDTM deliveries managed internally
- Attend meetings as applicable with Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase
- Perform relevant quality checks and create standard edit checks for new CRF modules and share in the appropriate space
Requirements:
- At least 5 years relevant SAS experience preferred
- Experience with Biometrics processes
- Review of SDTM annotated CRFs
- Writing and reviewing technical specifications
- Review of log files for errors and warnings
- Resolving/trouble shooting errors
- Experience with data mapping and SDTM Controlled Terminology
- Experience with SAS programming and SDTM deliveries
- Prior experience in a clinical or pharmaceutical related field is required
- Prior experience in a Data Management related field is required
- Experience with relational databases, preferably Clinical Data Management and EDC Systems
- Advanced familiarity with reporting tools
- Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
- Excellent command, both verbal and written, of English
Benefits:
- Remote working from anywhere in Europe or South Africa
- Collaborate with Sponsor colleagues and CRO Partners
- Support audits and inspections as required
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