Data Standards Engineer (CDISC)

About the role

This position is responsible for designing the end-to-end client standards and study specifications that align with CDISC standards and regulatory agency guidance. It sits within IQVIA's clinical research business and involves supporting clients and IQVIA as an authority on the use of CDISC standards.

Key responsibilities

• Support clients and IQVIA through communication, collaboration, training and mentorship on CDISC standards.
• Partner with project statisticians and programming teams to develop global tools supporting project programming needs under CDISC standards.
• Lead the implementation of productivity tools for IQVIA and clients that improve compliance, efficiency and timeliness of deliverables.
• Provide training and mentorship on technologies and systems such as metadata repositories.
• Ensure work delivered to clients meets minimum submission requirements defined by FDA guidance documents and other regulatory guidance.
• Guide clients in using CDISC standards through governance teams and monitor regulatory authority and standards organisation sites for updates.
• Work on other IQVIA initiatives as a CDISC representative and interact with CDISC-sanctioned teams in standards development.
• Represent IQVIA in the industry as a leader in standards and automation, and support leadership in developing processes and tools for CDISC compliance.

Required profile

• Bachelor's degree in computer science, statistics or a related area.
• Experience on an industry team involved in standards such as CDISC, HL7 or Transcelerate.
• Strong communication skills.
• Preferred: 10 years of SAS programming or equivalent programming experience, knowledge of macro or subroutine development, experience mentoring others in CDISC standards, and experience submitting to regulatory authorities.

Required skills

• Experience with CDISC standards, specifically SDTM and ADaM.
• Knowledge of two or more programming languages such as SAS, R, Python, Julia, C# or Java.
• Relevant statistical programming experience with pharmaceutical clinical trial data preferred.