Senior SpecialistFull Stack Developer- Clinical Data Operation

Initial Therapeutics, Inc.; India; Hybrid; INR 900,000 - 1,200,000; Full time

Job summary

Initial Therapeutics, Inc. is hiring a Senior Specialist, Data Quality & Insights for our hybrid data management team in Hyderabad, India. This role involves end-to-end validation and oversight of clinical data while collaborating with various stakeholders to enhance data quality processes.

The ideal candidate will have 4-6 years of experience in clinical data management, a Bachelor’s or Master’s degree, and proficiency in SQL and Python. We are committed to an inclusive workplace and welcome all qualified applicants.

Qualifications

• 4-6 years of experience in clinical data management or reconciliation.
• Strong expertise in Central Lab, Imaging, PK/PD, and Biomarkers.
• Knowledge of Clinical Data Acquisition Standards Harmonization (CDASH).

Responsibilities

• Perform reconciliation across external clinical data.
• Develop Python and SQL reconciliation scripts.
• Coordinate vendor issue resolution for data discrepancies.

Skills

Clinical data management

Data reconciliation

Python

SQL

Automated reporting

Collaboration

Education

Bachelors or Masters in Life Sciences, Data Science, or related field

Tools

Medidata Rave

SAS

Cloud-based data lake platforms

Job description

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, Data Quality & Insights to join our Data Management team, supporting our clinical data operations in India in a hybrid work model. In this role, you will perform end-to-end reconciliation, validation, and quality oversight of external clinical data while collaborating with Data Management, Pharmacometrics, Imaging, Precision Medicine, Biomarker Sciences, GD-IT, and Data Acquisition teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Hyderabad, India (Hybrid)

Discover your role:

• Perform reconciliation across external clinical data and EDC systems
• Develop Python and SQL reconciliation scripts and ETL pipelines
• Investigate data discrepancies and coordinate vendor issue resolution
• Execute protocol-aligned data quality timelines and validation checkpoints
• Build automated reporting pipelines and operational quality dashboards
• Generate vendor KPIs and present findings in operational meetings
• You collaborate effectively across global cross-functional stakeholder teams
• You apply analytical thinking to improve data quality processes continuously

This role requires:

• Bachelors or Masters degree in Life Sciences, Data Science, Computer Science, Bioinformatics, or a related field
• 46 years of experience in clinical data management or external data reconciliation within the pharmaceutical or biotechnology industry
• Strong expertise in external clinical data domains including Central Lab, Imaging, PK/PD, Cytokines, eCOA, and Biomarkers
• Proficiency in SQL, Python, SAS, and cloud-based data lake platforms
• Hands-on experience building automated reconciliation scripts, ETL pipelines, and data quality checksExperience working with EDC systems such as Medidata Rave
• Knowledge of Clinical Data Acquisition Standards Harmonization (CDASH) standards and protocol schedule management
• Experience collaborating with global teams across multiple external data modalities

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.