About the role
Build our future together
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, while redefining our understanding of health.
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Specialist - Data Quality & Insights to join our Data Management team in Hyderabad. In this hands-on role, you will lead the reconciliation, validation, and quality oversight of external vendor data across multiple clinical data types. You will use Python, SQL, ETL tools, and data-quality reporting solutions to identify and resolve discrepancies, improve vendor data quality, strengthen inspection readiness, and support reliable clinical decision-making across the portfolio.
When & where
Hyderabad, India
Discover your role
• Perform end-to-end reconciliation of external vendor data, including Central Lab, Imaging, PK/PD, Cytokines, eCOA, and Biomarker data, against Medidata Rave and the Clinical Data Lake.
• Develop and maintain Python- and SQL-based reconciliation scripts, ETL pipelines, and automated data-quality checks for incoming external vendor datasets.
• Investigate, document, and coordinate the resolution of data discrepancies with Data Acquisition teams, vendors, and cross-functional partners, tracking issues through closure and CAPA processes where applicable.
• Execute study-specific data-quality timelines and checkpoints to ensure external data is validated and reconciled in line with protocol schedules and regulatory expectations.
• Implement and enhance Flask/Python-based reporting solutions used to publish data-quality reports and automated QC outputs for clinical and scientific stakeholders.
• Create and maintain vendor quality metrics and KPIs, including error rates, reconciliation timeliness, and protocol deviation trends, and communicate findings during vendor operational meetings.
• Develop data-quality dashboards and vendor scorecards that support inspection readiness, audit traceability, and continuous improvement.
• Partner with GD-IT and Data Acquisition teams on the ingestion, transformation, staging, and mapping of raw vendor data within the Clinical Data Lake.
This role requires
• Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, Bioinformatics, or a related field.
• 4-6 years of hands-on experience in clinical data management, external data reconciliation, or clinical data quality within the pharmaceutical or biotechnology industry.
• Deep working knowledge of external clinical data types, such as Central Lab, Imaging, PK/PD, Cytokines, eCOA, and Biomarkers, including flow cytometry, genomic, or proteomic datasets.
• Hands-on expertise in Python and SQL for data analysis, automation, reconciliation scripting, ETL pipelines, and data-quality checks. SAS experience is also relevant.
• Experience working with cloud data-lake platforms such as Dremio, Snowflake, or similar technologies.
• Proficiency with EDC systems, particularly Medidata Rave, and experience reconciling vendor data against clinical systems.
• Strong knowledge of CDASH standards, protocol schedules of events, protocol amendments, and study-specific data-mapping requirements.
• Experience partnering with global and cross-functional teams, with strong problem-solving, communication, and stakeholder-management skills.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are
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