Data Standards Engineer

Description

This role develops end-to-end designs for client standards and study specifications that follow CDISC standards and regulatory agency guidance.

The company is a global provider of clinical research services, commercial insights and healthcare intelligence to life sciences and healthcare organisations.

Responsibilities

• Act as the go-to expert on CDISC standards for the company and its clients, sharing knowledge through communication, collaboration, training and mentoring.
• Work with project statisticians and programming teams to build shared tools that support CDISC-based programming across projects.
• Lead the rollout of productivity tools that improve compliance, efficiency and on-time client deliveries.
• Teach the company and its clients how to use technology and systems such as metadata repositories.
• Check that deliverables meet the minimum submission requirements set by FDA guidance and other regulators.
• Guide clients on their use of CDISC standards through their governance teams.
• Track updates on regulatory authority and standards body websites and report them to company leadership.
• Represent the company on other initiatives as its CDISC representative.
• Work with CDISC-sanctioned teams on the development of standards.
• Represent the company externally as a leader in standards and automation.
• Help leadership build processes and tools that enable CDISC compliance.

Requirements

• Bachelor's degree in computer science, statistics or a related area.
• Experience with CDISC standards, specifically SDTM and ADaM.
• Experience on an industry team working on standards such as CDISC, HL7 or Transcelerate.
• Strong communication skills.
• Experience mentoring and developing others in the use of CDISC standards.
• Knowledge and experience in two or more programming languages, such as SAS, R, Python, Julia, C, Java or others.
• Knowledge of macro or subroutine development is expected.
• 10 years of SAS programming experience, or experience in another related programming language, preferred.
• Relevant statistical programming experience with pharmaceutical clinical trial data, preferred.
• Experience in submissions to regulatory authorities, preferred.

Conditions

All information and credentials in your application must be truthful and complete, as false statements or material omissions can lead to disqualification or later termination in line with applicable law.