Purpose:
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 environments

📌 Statistical Programmer (India)
🏢 Veramed
📍 India