Data Standards Engineer (CDISC) - m/w/d

Data Standards Engineer (CDISC) - m/w/d

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.
• Strong analytical and problem-solving skills, with the ability to interpret standards and regulatory guidance and apply them appropriately to complex study-specific scenarios.
• Strong attention to detail, with a focus on accuracy, consistency, quality, and compliance with applicable standards and regulatory requirements.
• Strong communication, collaboration, and negotiation skills, including the ability to effectively communicate and defend standards-related recommendations and achieve alignment across different stakeholders.
• Ability to critically evaluate study-specific requirements, challenge proposed approaches where appropriate, and develop pragmatic solutions while maintaining standards compliance.
• Ability to work independently, exercise sound judgment, and make well-reasoned standards-related decisions.
• Ability to manage multiple priorities and work effectively within cross-functional and global teams.
• More than 6 years of SAS programming experience is preferred. Experience with additional programming languages, such as R or Python, is advantageous.
• Experience mentoring and developing others in the interpretation and application of CDISC standards.
• Experience supporting submissions to regulatory authorities is preferred.
• Demonstrated interest and active involvement in standards-related activities, either within or outside the company, is expected, for example through CDISC, PHUSE, TransCelerate, or other relevant industry initiatives.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.