This function supports the protection of patient privacy when clinical trial data is shared externally.
Typical use cases
Regulatory submissions
Data sharing with researchers
Health authority requests
External collaborations
Clinical trial transparency initiatives
Typical responsibilities:
Review datasets for personally identifiable information (PII).
Apply anonymization methodologies.
Remove or mask sensitive variables.
Assess re-identification risk.
Create anonymized SDTM and ADaM datasets.
Produce anonymization reports and documentation.
Validate anonymized outputs.
Key technical skills:
SAS programming.
SDTM and ADaM expertise.
Clinical trial disclosure processes.
Metadata and standards expertise.
Knowledge of data privacy regulations:
GDPR
HIPAA
EMA Policy 0070
Ideal profile:
Clinical programming teams.
Regulatory programming.
Clinical disclosure teams.
Data transparency functions.
4+ Years of relevant experience
Success factors:
Meticulous attention to detail
Robust compliance mindset
Understanding of patient privacy regulations
Process-oriented approach
Ability to work within heavily governed settings