About the job
Position Summary:
The Senior Clinical Data Engineer is pivotal in the strategic advancement and enhancement of clinical data systems, ensuring alignment with regulatory standards, facilitating advanced analytics, and promoting operational excellence across global clinical trials. This role spearheads enterprise-level data standardization projects and designs scalable validation frameworks, effectively addressing systemic data challenges. With extensive expertise in programming languages such as Python, R, SQL, and SAS, the engineer develops and sustains modular codebases, establishes coding standards, and provides mentorship to junior engineers. The position also involves ensuring compliance with regulatory requirements such as GCP and FDA 21 CFR Part 11 by creating comprehensive documentation and audit trail protocols. Utilizing dynamic dashboards and analytical tools, the engineer provides actionable insights into trial performance and data quality. Acting as a strategic liaison among Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates clinical requirements into scalable technical solutions, leading the design of secure, high-performance databases and ETL pipelines that integrate data from various clinical systems.
Essential Functions:
- Data Standardization & Mapping: Lead the creation of enterprise-level data mapping strategies to convert raw clinical data into standardized formats for impactful analytics. Ensure governance of data standards across programs for regulatory compliance and consistency.
- Data Quality Assurance: Develop and implement robust validation frameworks that proactively identify and mitigate systemic data issues, collaborating closely with Clinical Data Managers and cross-functional teams to enhance data integrity across global trials.
- Programming & Scripting: Design and maintain advanced modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows. Set coding standards and mentor junior engineers in automation, reproducibility, and performance optimization.
- Regulatory Compliance & Documentation: Lead initiatives to ensure data systems and workflows align with GCP, FDA 21 CFR Part 11, and evolving global regulatory standards. Establish documentation protocols and oversee audit trail governance for inspection readiness.
- Reporting & Visualization: Develop and operationalize dynamic dashboards and analytics tools, delivering insights into trial performance and data quality.

