Role Summary
Sr. Clinical Data Engineer responsible for designing, implementing, and maintaining data infrastructure and solutions to support clinical trials and development programs. Collaborates with Clinical Operations & Development, Biometrics, and IT teams to develop data pipelines, integrate clinical systems, and deliver analytical solutions enabling data-driven decision-making throughout the trial lifecycle. Builds scalable data models and transformation workflows to support analytics and machine learning initiatives.
Responsibilities
- Collaborate with team members to develop and maintain data solutions for clinical stakeholders
- Empower scientists, researchers, and management with efficient access to high-quality data insights
- Maintain and create end-to-end solutions, including data ingression, modeling, and visualization
- Design and implement data models optimized for analytical querying, reporting, and ML workflows
- Solve challenges related to multi-model data sources, harmonization, and normalization
- Provide technical leadership in evaluating and implementing new tools and technologies
- Assist in management and selection of optimal data transfer approaches among different vendors
- Develop and deploy end-user facing solutions to production using SDLC best practices
- Create and maintain documentation to support development work, definitions, and business rules
- Adhere to regulatory guidelines (e.g., GxP, HIPAA, GDPR) and security policies in handling data
- Act as a data and analytical consultant to stakeholders on data utility issues
- Support the clinical team with planning and execution of clinical studies
Qualifications
- Required: Bachelor's Degree in Computer Science, Engineering, Bioinformatics, or related field and 4+ years in an analytical capacity with development/maintenance of reports
- OR: Master's Degree in Computer Science, Engineering, Bioinformatics, or related field and 2+ years as noted above
- Demonstrated passion for practically solving complex problems with technology
- Excellent communication skills and ability to work with cross-functional teams
- Ability to manage multiple priorities to meet deadlines
- Prior bio/pharma experience is highly preferred, but not required
- Demonstrated experience implementing production data models and analytical solutions
- Strong programming skills in Python and other modern languages
- Strong expertise in database design, SQL optimization, and data modeling patterns
- Strong expertise with cloud infrastructure and computing platforms; AWS experience preferred
- Advanced knowledge of clean code principles, testing methodologies, GitHub, and CI/CD tools
- Advanced knowledge in data analysis, exploration, and visualization tools
- Experience with statistical concepts and methods (descriptives, probability, hypothesis testing)
- Familiarity with clinical data standards (CDISC, SDTM, ADaM) and GCP regulatory guidelines
Education
- As listed in Qualifications