Principal Statistical Programmer - Lead 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, leading programming support for analysis datasets, tables, listings and graphs across the clinical portfolio.

Location is Warren, NJ or Cambridge, MA with onsite work; the role combines independent programming leadership with collaboration in a multidisciplinary study team to drive regulatory submissions and study deliverables.

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

Skills

Statistical programming

Clinical data

Documentation

Regulated environment

Multidisciplinary collaboration

Education

Master's degree

Job description

Regeneron is seeking a Principal Statistical Programmer to join our Statistical Programming team, leading programming support for analysis datasets, tables, listings and graphs across the clinical portfolio.

Location is Warren, NJ or Cambridge, MA with onsite work; the role combines independent programming leadership with collaboration in a multidisciplinary study team to drive regulatory submissions and study deliverables.