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Regeneron

biopharmaceutical manufacturing · FDA-approved medicines

Senior Manager - Full Stack Developer- Clinical Data Operation

HyderabadPosted 2 months ago
Software engineeringSenior
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About Regeneron

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 those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

As a Senior Manager – Clinical Data Solutions & Insights, you will be responsible for designing, building, and handling a centralized clinical reporting platform that consolidates reporting outputs across Data Management and external vendor reconciliation activities into a single governed reporting layer. This role will be responsible for the end-to-end reporting lifecycle including data ingestion, analytical dataset development, dashboard creation, automated reporting, and self-service analytics applications using modern visualization and web technologies. You will work closely with Clinical Sciences, Data Management, Pharmacometrics, Precision Medicine, Safety, and multi-functional collaborators to deliver intuitive, audit-ready reporting solutions that support data-driven decision making, regulatory compliance, and operational perfection.

This position is office-based and will be on site at Regeneron’s Hyderabad office.

A Typical Day May Include: Owning the design and delivery of a centralized clinical reporting platform consolidating EDC listings, exception reports, and vendor reconciliation outputs

Building and maintaining Clean Patient Tracker applications providing real-time access to CRF completion, visit status, data queries, freeze/lock status, and PI signature status

Developing executive-level dashboards highlighting portfolio-wide KPIs such as query aging, protocol deviations, data entry lag, and study completion achievements

Partnering with Data Management Reporting teams and external vendor delivery teams to establish structured data ingestion pipelines for EDC and reconciliation reports

Collaborating with Clinical Sciences, Biostatistics, Safety, and Precision Medicine teams to develop validated self-service analytical tools and reporting applications

Designing and implementing data visualization standards, UX/UI guidelines, and reporting procedures for non-technical stakeholders

Building curated analytical datasets and semantic layers connected to clinical data lakes and vendor reconciliation feeds

Running the full reporting lifecycle including requirements gathering, UX wireframing, development, validation, UAT coordination, and production deployment

Driving automation across routine reporting workflows including scheduled data ingestion, reconciliation report generation, and alert-based notifications

Supporting GCP compliance, inspection readiness, report governance, version control, and audit trail management

Driving adoption of reporting tools through stakeholder engagement, training, and change management initiatives

Serving as an SME for clinical data reporting, embedded analytics, and emerging visualization technologies

This Role May Be For You If You Have: Demonstrable experience in Clinical Data Management, clinical trial reporting, analytics, or reporting platform development

Hands-on experience with Medidata Rave EDC including query management workflows and dataset structures

Solid understanding of CDISC CDASH/SDTM standards and GxP/CSV validation principles

Experience developing reporting applications using Python frameworks such as Dash, Streamlit, or Flask

Demonstrable experience with Power BI, Tableau, SQL, and analytical dataset development

Experience working with clinical data sources, clinical metrics, and external vendor reconciliation outputs

Strong UX/UI design sensibility for building intuitive reporting tools for non-technical users

Excellent stakeholder management, communication, and presentation skills

Strong analytical thinking and problem-solving capabilities

Ability to work optimally in a fast-paced, matrixed, and multi-functional environment

To Be Considered For This Role, You Must Have: 8+ years of experience in Clinical Data Management or clinical trial operations

Minimum 3+ years focused on clinical data reporting, analytics, or reporting tool development

Experience with clinical reporting applications, dashboards, and data visualization tools

Bachelor’s or Master’s degree in Computer Science, Data Science, Bioinformatics, or a related field

Advanced degree (MBA/MS) preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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, 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/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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.

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