Senior Specialist – Data Lake Operations

Regeneron India Private Limited; Hyderabad; Hybrid; INR 1,500,000 - 2,100,000; Full time

Job summary

Regeneron India Private Limited in Hyderabad is seeking a Senior Specialist, Clinical Data Lake Operations to drive daily data lake operations and ensure quality oversight of GxP clinical data workflows within a hybrid work model.

You will collaborate with Safety, Clinical Sciences, Biostatistics, and external partners to onboard data sources, build standardized data structures, and develop data marts for clinical and safety applications while advancing data governance.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Data Science, Bioinformatics, or a related field
• 4+ years of experience in clinical data engineering and data lake management
• Strong expertise in Python, ETL frameworks, SQL, and automation development
• Experience with clinical trial data systems and CDISC SDTM/ADaM
• Familiarity with EDC systems such as Medidata Rave
• Experience with cloud platforms including AWS, Snowflake, Dremio
• Knowledge of GxP, ICH-GCP, and 21 CFR Part 11 regulatory requirements
• Advanced degree such as MBA or MS preferred

Responsibilities

• Complete daily clinical data lake operations and pipeline monitoring
• Onboarding and validation of non-EDC clinical data sources
• Build reusable clinical data structures aligned with data standards
• Develop data marts supporting clinical and safety applications
• Maintain governance documentation, metadata, and audit-ready traceability
• Write Python automation frameworks for validation and data delivery
• Collaborate effectively across cross-functional clinical data stakeholders
• Apply analytical thinking to strengthen data quality and governance

Skills

Python

ETL frameworks

SQL

Data governance

Cross-functional

Education

CS/DS/Bioinformatics

Tools

Medidata Rave

AWS

Snowflake

Dremio

Job description

Role Summary

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Specialist, Clinical Data Lake Operations to join our Data Management team, supporting our clinical data operations in a hybrid work model. In this role, you will execute, maintain, and ensure quality oversight of GxP clinical data lake operations while collaborating with Safety, Clinical Sciences, Biostatistics, Precision Medicine, external partners, and Data Management teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location

Hyderabad, India (Hybrid)

Responsibilities

• Complete daily clinical data lake operations and pipeline monitoring
• Perform onboarding and validation of non-EDC clinical data sources
• Build reusable clinical data structures aligned with data standards
• Develop data marts supporting clinical and safety applications
• Maintain governance documentation, metadata, and audit-ready traceability
• Write Python automation frameworks for validation and data delivery
• You collaborate effectively across cross-functional clinical data stakeholders
• You apply analytical thinking to strengthen data quality and governance

Requirements

• Bachelor’s or Master’s degree in Computer Science, Data Science, Bioinformatics, or a related field
• 4+ years of experience in clinical data engineering and data lake management
• Strong expertise in Python, ETL frameworks, SQL, and automation development
• Experience with clinical trial data systems and clinical data standards including Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM)
• Familiarity with Electronic Data Capture (EDC) systems such as Medidata Rave
• Experience with cloud platforms including AWS, Snowflake, Dremio, or similar query engines
• Knowledge of GxP, ICH-GCP, and 21 CFR Part 11 regulatory requirements
• Advanced degree such as MBA or MS preferred

Equity & Inclusive Culture

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.

Salary and Benefits

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, and 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/.

Onsite Expectations

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.

Recruiter Contact

If you have any questions, please speak with your recruiter.

Additional Information

For jobs in Canada: this posting is for an existing position. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.