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.

- Strong compliance mindset.

- Understanding of patient privacy regulations.

- Process-oriented approach.

- Ability to work within heavily governed environments.