Manager Clinical Data Reporting

Responsibilities

• Lead the design, development, and maintenance of standardized clinical data reports and listings to support clinical trial oversight.
• Partner with cross-functional teams to translate reporting requirements into high-quality, accurate, and timely outputs.
• Deliver participant-level listings, exception reports, and reconciliation outputs to enable efficient data cleaning and review.
• Drive reporting solutions that provide actionable insights for operational performance and decision-making.
• Collaborate with data management and technology teams to leverage EDC systems, data lakes, and external data sources.
• Identify opportunities for automation and process improvement to enhance reporting efficiency and scalability.
• Ensure compliance with regulatory requirements such as GCP, ICH, and data privacy standards.
• Provide guidance and mentorship to team members and contribute to team development.

Requirements

• Bachelor’s or Master’s degree in Data Science, Computer Science, Life Sciences, or a related field.
• 7+ years of experience in clinical data, reporting, or related domains.
• Strong hands-on experience in clinical data reporting, analytics, and visualization.
• Experience working in a regulated clinical or pharmaceutical environment.
• Proficiency in reporting and visualization tools such as SAS, R, Tableau, Power BI, or Spotfire.
• Experience with EDC systems such as Medidata Rave.
• Strong knowledge of CDISC standards and regulatory requirements.

Preferred Qualifications

• Experience with data integration, data lakes, data pipelines, and automation frameworks.
• Strong knowledge of data lifecycle management and risk-based data review concepts.
• Excellent problem-solving, communication, and stakeholder management skills.

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to translate science into medicine has led to numerous FDA-approved treatments and a robust pipeline of product candidates.