Principal Statistical Programmer

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

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Statistical Programmer to join our Statistical Programming team, supporting a study team across our clinical portfolio. In this role, you will provide programming leadership and support for processing clinical trial data, designing and testing program logic while ensuring consistent, high-quality documentation, all while collaborating with a multidisciplinary study team to support analysis and reporting through regulatory approval and beyond.

When & Where

• Location: Warren, NJ or Cambridge, MA
• Work model/flexibility: onsite

Discover Your Role

• 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

This Role Might Be For You If You

• Enjoy working independently while staying closely connected to a broader study team
• Communicate clearly and proactively, especially around shifting timelines
• Take pride in accuracy and consistency when documenting and maintaining code
• Think analytically and enjoy solving programming and data challenges
• Stay curious about process improvement and enjoy contributing ideas to working groups
• Adapt comfortably to ad hoc requests and evolving priorities from senior leadership
• Bring attention to detail and a quality mindset to regulated work

This Role Requires

• 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

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$109,900.00 - $179,300.00

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits