Offer summary

Qualifications:

Bachelor's Degree in Maths, Computer Science, Statistics, or related field., 7+ years of experience in the Life Science and Pharmaceutical Industry., Strong SDTM Programming experience and advanced knowledge of statistics and clinical drug development processes., Proficiency in Base SAS, SAS Graph, SAS Macros, and advanced CDISC knowledge..

Key responsabilities:

Review and provide input into trial set-up documentation and create detailed technical specifications.

Develop Data Review Models (DRM) and SDTM datasets according to current standards.

Perform quality control of clinical programming deliverables and manage data-cut activities for reporting milestones.

Create and validate electronic submission packages for regulatory compliance with agencies like FDA and EMEA.

Job description

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

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