Senior Clinical Programmer (SDTM)

• 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 6 years of relevant experience in SDTM Clinical Programming
• Advanced 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 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.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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