Specialist, Clinical Data Reporting

Initial Therapeutics, Inc.; India; On-site; INR 700,000 - 900,000; Full time

Benefits offered by this job

Annual bonuses or incentive plans

Health and wellness programs

401(k) company match

Job summary

Initial Therapeutics, Inc. is looking for a Clinical Data Specialist in Hyderabad, India. This hybrid role involves programming standardized clinical data reports and communication with cross-functional partners.

The ideal candidate will hold a Bachelor's or Master’s degree and have over 2 years of relevant experience, including proficiency with EDC systems and data visualization tools. Attractive benefits and a supportive work environment await you.

Qualifications

• 2+ years of experience in clinical data or related disciplines.
• Strong understanding of clinical trial processes and regulatory requirements.
• Experience with data lakes and data integration in a clinical research environment.

Responsibilities

• Program and maintain standardized clinical data reports.
• Communicate with cross‑functional partners to clarify reporting needs.
• Monitor routine data refreshes and troubleshoot issues.

Skills

Data visualization

EDC systems (Medidata RAVE)

Analytics tools (SAS, R, Python)

Clinical data standards (CDISC)

Education

Bachelor's or Master’s degree in Data Science, Computer Science, Life Sciences, or related field

Tools

Power BI

Tableau

Spotfire

Job description

When & where:

Hyderabad, India (hybrid)

Discover your role:

• Program and maintain standardized clinical data reports and listings used for participant-level data review, data cleaning, and operational oversight
• Translate study reporting requirements into technical specifications and implement outputs using established frameworks and data standards
• Build and validate data review listings, exception reports, reconciliation outputs between EDC and external data, and operational performance reports
• Communicate clearly with cross‑functional partners to clarify reporting needs and deliver outputs on schedule
• Partner with clinical data management and technology teams to leverage data sources including the Scientific Data Lake, EDC systems, and external data streams
• Monitor routine data refreshes, troubleshoot issues with accuracy, completeness, and integration, and contribute to automation and workflow streamlining
• Keep reporting documentation, specifications, and outputs audit‑ and inspection‑ready in line with GCP, ICH, GDPR, SOPs, and internal quality standards
• Stay curious about reporting tools and methodologies, sharing knowledge of standards and processes to support team learning and continuous improvement

This role requires:

• Bachelor's or Master’s degree in Data Science, Computer Science, Life Sciences, or a related field
• 2+ years of experience in clinical data, data visualization, or related disciplines, with a background in building interactive reporting solutions, KPIs, and metrics to support clinical trial oversight
• Proficiency in EDC systems (e.g., Medidata RAVE) and analytics, reporting, and data visualization tools such as SAS, R, Python, JReview, elluminate, Tableau, Power BI, or Spotfire
• Strong understanding of clinical trial processes, clinical data standards (e.g., CDISC), and regulatory requirements (GCP, GDPR, HIPAA)
• Experience with risk‑based data review concepts, data quality standards, and data lifecycle management in a regulated environment
• Experience with data lakes, data pipelines, data integration, automation, and reporting and analytics in a clinical research environment

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, reasonable accommodation will be provided to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

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/.