Job Responsibilities:

• Support clients and IQVIA as an authority in the use and application of CDISC standards through communication, collaboration, training, and mentorship.
• Partner with project statisticians and programming teams to develop global tools that support project programming needs and the effective implementation of CDISC standards.
• Lead the implementation of productivity tools for IQVIA and clients to improve compliance, efficiency, and timeliness of deliverables.
• Provide training and mentorship in the use of technology and systems, such as metadata repositories, to support IQVIA and clients in the implementation and management of standards.
• Ensure that work delivered to clients meets minimum submission requirements as defined by FDA guidance and other applicable regulatory guidance.
• Guide clients in the interpretation and application of CDISC standards through governance teams.
• Monitor regulatory authority and standards organization websites for updates and communicate relevant changes to IQVIA leadership.




• Contribute to other IQVIA initiatives as a CDISC standards representative.
• Participate in CDISC and other relevant industry standards teams and initiatives.
• Represent IQVIA within the industry as a leader in the use of standards and automation.
• Support leadership in the development and continuous improvement of processes and tools that enable CDISC compliance.

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Minimum Requirements:

• Bachelor’s degree in Computer Science, Statistics, Life Sciences, or a related field.
• Extensive knowledge of and experience with CDISC standards, including:• SDTM: minimum of 7 years of experience.
• ADaM: minimum of 5 years of experience.
• Experience with CDASH is desirable.

• Experience participating in industry standards initiatives or working groups, such as CDISC, HL7, TransCelerate, PHUSE, or similar organizations.
• Solid analytical and problem-solving skills, with the ability to interpret standards and regulatory guidance and appl

📌 Data Standards Engineer (Hyderabad)
🏢 Iqvia
📍 Hyderabad