Mgr, Clinical Data Reporting

Regeneron Pharmaceuticals • Warren, MI

21h • Onsite

About The Position

The Mgr, Clinical Data Reporting will lead the development, delivery, and maintenance of high-quality clinical data reporting solutions, essential for efficient data review, operational oversight, and the generation of reports and listings across clinical development programs. This role involves transforming complex clinical and operational data into clear, reliable, consistent, and actionable reports by leveraging established data management processes, enterprise data sources, and standardized reporting frameworks. Responsibilities include creating participant-level data review listings, exception reports, external data reconciliation outputs, and reports to monitor and improve operational oversight and performance. The role requires strong expertise in clinical data programming, clinical data management processes and systems, external data reconciliation, and reporting methodologies. The ideal candidate will work closely with cross-functional teams to ensure reporting needs are met across studies, while driving consistency, accuracy, and continuous improvement in reporting practices.

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, data visualization, or related disciplines, with a strong background in creating 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 JReview, elluminate, SAS, R, Tableau, Power BI, or Spotfire.
• Experience with risk-based data review concepts, data quality standards, and strong understanding of data lifecycle management in a regulated environment.
• Strong understanding of clinical trial processes, clinical data standards (e.g., CDISC), and regulatory requirements (e.g., GCP, GDPR, HIPAA).
• Experience with data lakes, data pipelines, data integration, automation, reporting and analytics in a clinical research environment.
• Excellent communication and stakeholder management skills.

Responsibilities

• Lead the design, build, and maintenance of standardized clinical data reports and listings that support participant-level clinical data review, data cleaning, and operational oversight across clinical development programs.
• Engage with cross-functional teams to understand the study reporting requirements and translate them to reporting specifications, ensuring outputs are of high-quality, accurate, timely, and aligned with data management and regulatory expectations.
• Ensure that the clinical data reporting solutions provide actionable insights to improve clinical data oversight, facilitate efficient data cleaning and review, monitor operational performance, enable improved visibility and decision-making.
• Partner with clinical data management and technology partners to ensure that the reporting solutions effectively utilize the Scientific Data Lake, EDC system, and external data streams.
• Provide subject matter expertise on reporting capabilities, data structures, and data review workflows.
• Identify opportunities to streamline reporting processes, automate manual tasks, and improve reporting efficiency and consistency.
• Monitor data flows and troubleshoot issues related to accuracy, data completeness, and refresh cycles.
• Support inspection readiness by ensuring reporting outputs and documentation are complete, traceable, and audit ready.
• Deliver operational insights to identify risks, bottlenecks, and opportunities to drive process improvements and optimization initiatives.
• Ensure all data reporting workflows and outputs are validated, documented, and compliant with GCP, ICH, GDPR, SOPs, and regulatory expectations.
• Support training efforts related to reporting tools, standards, and processes.
• Contribute to the development and enhancement of reporting frameworks, documentation, and best practices.
• Provide leadership and guidance to junior team members engaged in reporting, data review, or data integration activities.
• Stay updated on emerging technologies and tools in data reporting methodologies and approaches to enhance business capabilities.
• Drive the adoption of innovative reporting solutions to improve the efficiency and scalability of clinical data reporting solutions.
• Foster a culture of collaboration, innovation, and continuous improvement within the Clinical Data Operations team.

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other countries’ specific benefits, please speak to your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager