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Accelerate innovation for a healthier world.
Senior Clinical Programmer, SDTM
Location
South Africa
Posted
92 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Programmer, SDTM
IQVIA
• Review and provide input into all trial set-up documentation • Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc. • Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standards • Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review • QC of all clinical programming deliverables • Perform unblinding, data-cut activities for planned reporting milestones and database locks • Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed • Support the development of standards and drive implementation within the organization
Job Requirements
- Minimum 4+ years of relevant experience in SDTM Clinical Programming
- Good knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.)
- Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc.
- Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus
- Demonstrated understanding of current industry standards for submission of clinical trial data
- Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects
- Ability to communicate with cross-functional teams, and business partners and gather feedback for study specifications and/or data issues.
Benefits
- Health insurance
- Professional development
- Flexible work arrangements
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