Statistical Programmer - Data Analytics

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.