Sr. Specialist Data Quality & Insights

Regeneron Pharmaceuticals; Hyderabad; Sur place; INR 2 800 000 - 4 000 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals in Hyderabad seeks a Senior Specialist to lead data quality and insights for external vendor data. You will implement reconciliation scripts, QC checks, and data-quality dashboards across clinical datasets, collaborating with Data Acquisition and IT teams to ensure inspection readiness.

Maintain and enhance reporting solutions, metrics, and KPIs for governance and regulatory compliance, supporting reliable decision-making across the portfolio.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Data Science, CS, or Bioinformatics.
• 4-6 years of hands-on clinical data management or data quality experience.
• Deep knowledge of Central Lab, Imaging, PK/PD, Cytokines, eCOA, and Biomarkers.
• Proficiency in Python and SQL for data analysis, automation and QC; SAS experience is relevant.
• Experience with cloud data-lake platforms (Dremio/Snowflake) and Medidata Rave.
• Experience reconciling vendor data with clinical systems and strong stakeholder skills.

Responsabilités

• End-to-end reconciliation of external vendor data against Medidata Rave and Clinical Data Lake.
• Develop Python- and SQL-based reconciliation scripts and ETL pipelines.
• Investigate and document data discrepancies; coordinate CAPA where applicable.
• Meet study data-quality timelines and regulatory expectations.
• Develop Flask/Python-based reporting solutions for QC outputs.
• Create vendor quality metrics and KPIs; present findings in vendor meetings.
• Build data-quality dashboards and vendor scorecards for inspection readiness.
• Collaborate with GD-IT and Data Acquisition on data ingestion and mapping.

Connaissances

Python

SQL

Data quality

ETL

Medidata Rave

Formation

Bachelor’s or Master’s in Life Sciences / Data Science / CS / Bioinformatics

Outils

Dremio

Snowflake

ETL tools

Description du poste

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? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.