CDISC & eSubmission Standards SME – Manager

CDISC & eSubmission Standards SME – Manager
We’re looking for a CDISC & eSubmission Standards Subject Matter Expert (SME) – Manager to join our Biometrics Innovation & Statistical Programming team.
This is an exciting opportunity to play a key role in strengthening CDISC standards, supporting regulatory submissions, and ensuring clinical data packages are high quality, compliant and inspection-ready for global health authorities.
What You’ll Be Doing
In this role, you’ll provide hands-on CDISC and eSubmission expertise across clinical studies, including:
Developing and maintaining internal CDISC standards, templates and SOPs covering SDTM, ADaM, Define-XML and Reviewer’s Guides (cSDRG/ADRG).
Providing study-level guidance on SDTM and ADaM compliance, standards exceptions and transition rules.
Authoring, reviewing and QCing aCRFs, SDTM/ADaM mapping specifications and variable-level metadata.
Reviewing and QCing CRO deliverables, including SDTM, ADaM, Define-XML and submission data packages.
Supporting eCTD data package assembly and NDA/BLA submission activities.
Running and reviewing Pinnacle 21 validation outputs, investigating findings and developing appropriate justifications.
Ensuring robust SDTM → ADaM → TLF traceability, particularly for key study endpoints.
Partnering with Biostatistics, Data Management and Clinical Operations to resolve study-specific standards issues.
Supporting audit and inspection readiness, while helping train internal teams and vendors on CDISC standards and conventions.
What We’re Looking For
You’ll bring:
Strong working knowledge of CDISC standards, particularly SDTM and ADaM.
Hands-on experience with Define-XML and SDRG/ADRG.
2–3+ years of experience working as a CDISC SME within another organisation.
Practical experience with Pinnacle 21 Community/Enterprise and clinical data traceability.
Experience reviewing and QCing CRO deliverables and managing issue logs.
Excellent communication and collaboration skills, with the ability to work effectively across multidisciplinary study teams.
A Bachelor’s degree or higher in Life Sciences, Statistics, Computer Science, Data Science or a related discipline.
8+ years of relevant pharmaceutical or biotechnology industry experience, with strong hands-on statistical programming and CDISC expertise.
Why This Opportunity?
You’ll have the opportunity to make a meaningful impact on clinical data quality, regulatory submission readiness and standards innovation, while working closely with experts across Biometrics, Statistics, Data Management and Clinical Operations.

Work arrangement
Yes