Senior Statistical Programmer Lead for Clinical Trials

BioSpace

New Jersey

On-site

USD 110,000 - 179,000

Full time

25 hours ago
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Job summary

Regeneron seeks a Principal Statistical Programmer to join our Statistical Programming team, supporting a study team across our clinical portfolio. Lead programming and QC of analysis datasets, tables, listings, and graphs, with documentation in a regulated environment.

You will design and test program logic, support regulatory submissions, and collaborate with multidisciplinary teams while adapting to evolving priorities from senior leadership.

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

Programming experience

Education

Master's degree

Job description

Regeneron seeks a Principal Statistical Programmer to join our Statistical Programming team, supporting a study team across our clinical portfolio. Lead programming and QC of analysis datasets, tables, listings, and graphs, with documentation in a regulated environment.

You will design and test program logic, support regulatory submissions, and collaborate with multidisciplinary teams while adapting to evolving priorities from senior leadership.

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