Senior Specialist – Data Lake Operations
Regeneron Pharmaceuticals, Inc. (company site, opens in a new tab)4+ yrsHyderabadOn-siteDirect career pageEst. 16–28 LPA
Posted 17h ago
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Job description
Structured overview of role & requirements
About This Role
- Manage daily operations and quality oversight of GxP clinical data lake and pipelines.
- Lead onboarding and validation of non-EDC clinical data sources; develop reusable clinical data structures and data marts for clinical and safety use.
- Maintain governance documents, metadata, and audit-ready traceability while automating validation and data delivery processes using Python.
Minimum Requirements
- Bachelor’s or Master’s degree in Computer Science, Data Science, Bioinformatics, or related field.
- Minimum 4 years’ experience in clinical data engineering and data lake management.
- Strong skills in Python, ETL frameworks, SQL, clinical trial data standards (CDISC, SDTM, ADaM), and familiarity with EDC systems such as Medidata Rave.
- Knowledge of GxP, ICH-GCP, and 21 CFR Part 11 regulatory requirements; experience with cloud platforms like AWS, Snowflake, or Dremio.
Ideal Candidate Profile
- Experienced in handling regulated clinical data environments with strong cross-functional collaboration skills involving Safety, Clinical Sciences, Biostatistics, and Data Management teams.
- Proficient in designing data marts and automation in clinical data lakes aligned with clinical and safety data standards.
- Capable of maintaining compliance and audit readiness through documentation and governance in a GxP-regulated setting.