Senior Statistical Programmer - Clinical Data & Submissions

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 for analysis datasets, tables, listings, and graphs, while ensuring documentation quality in a regulated environment.

You will coordinate timelines, create specifications, and support regulatory submissions across trials. Based onsite in Warren, NJ or Cambridge, MA, the role requires a Master's degree with 3+ years of experience and strong collaboration within

Qualifications

• Master's degree with 3+ years of relevant experience.
• Proven programming experience supporting clinical study data and analysis deliverables.
• Strong 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.

Job description

Regeneron is seeking a Principal Statistical Programmer to join our Statistical Programming team. You will lead programming for analysis datasets, tables, listings, and graphs, while ensuring documentation quality in a regulated environment.

You will coordinate timelines, create specifications, and support regulatory submissions across trials. Based onsite in Warren, NJ or Cambridge, MA, the role requires a Master's degree with 3+ years of experience and strong collaboration within