Senior Statistical Programmer – Clinical Trials Lead

BioSpace; New Jersey; On-site; USD 110,000 - 179,000; Full time

Job summary

Regeneron is seeking a Principal Statistical Programmer to join our Statistical Programming team. You will lead programming and quality control for analysis datasets, tables, listings, and graphs across the clinical portfolio, coordinating timelines within a multidisciplinary study team.

You will design and test program logic, maintain documentation in a regulated environment, and support submissions and regulatory activities through launch and beyond.

Qualifications

• Master's degree with 3+ years of relevant experience.
• Programming experience supporting clinical study data and analysis deliverables.
• Documentation and quality control skills within a regulated environment.
• Experience collaborating within a multidisciplinary study team.

Responsibilities

• Support or lead programming and quality control of analysis datasets, tables, listings, and graphs.
• Coordinate activities and communicate shifting timelines and milestones to the study team.
• Create and maintain programming specifications for analysis datasets across studies.
• Support creation and validation of submission requirements, including annotated CRFs and define documents.
• Work within a multidisciplinary study team to provide timely, quality support through regulatory approval and launch.
• Provide programming support for presentations and statistical ad hoc requests, assisting with more complex data as needed.
• Participate in department working groups, contributing to tool development and process improvement.
• Design and test program logic independently, maintaining documentation in a regulated environment.

Skills

Programming

Documentation

Quality control

Collaboration

Education

Master's degree

Job description

Regeneron is seeking a Principal Statistical Programmer to join our Statistical Programming team. You will lead programming and quality control for analysis datasets, tables, listings, and graphs across the clinical portfolio, coordinating timelines within a multidisciplinary study team.

You will design and test program logic, maintain documentation in a regulated environment, and support submissions and regulatory activities through launch and beyond.