Senior Clinical Programmer (SDTM) - homebased

Bloemfontein, South Africa Full time Home-based R

• 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

Experience

• 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.