Job Overview:
As a SDTM Programming Lead, you will provide advanced technical expertise to develop process methodology for the department to meet internal and external clients’ needs, across complex projects and studies.
Responsibilities
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) 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
Requirements:
• Bachelor's Degree in Maths, Computer science, Statistics, or related field
• 7+ years’ of experience within the Life Science and Pharmaceutical Industry
• Strong SDTM Programming experience
• Advanced knowledge of statistics, programming and/or clinical drug development process
• Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macros.
• Advanced CDISC Knowledge
Join IQVIA to see where your skills can take you
• Global exposure
• Variety of therapeutic areas
• Collaborative and supportive team environment
• Access to cutting-edge and innovative, in-house technology
• Excellent career development and progression opportunities
• Work-Life Balance, with a strong focus on a positive well-being
Unleash your potential!
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you’ll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward
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 https://jobs.iqvia.com
