Staff GMP Statistician

Principal Or Staff Statistician

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal or Staff Statistician to join our team, supporting advanced statistical leadership across a cross-functional, science-driven environment. In this role, you will drive root cause analysis, process improvement, and strategic deployment initiatives with a high degree of autonomy, while collaborating with manufacturing, quality, and executive stakeholders across Regeneron's manufacturing facility.

This position offers the opportunity to apply cutting-edge statistical and modeling techniques that directly accelerate drug development and approval at a global scale.

Location:

Troy, New York, United States

Work model:
Monday - Friday 8am - 4:30p

Discover your role:

• Lead identification and implementation of strategic deployment initiatives, operating autonomously within a collaborative team environment
• Apply advanced statistical modeling methods — including Bayesian and kinetic modeling — to historical data to accelerate process knowledge and inform earlier go/no-go decisions
• Build, validate, and maintain automation frameworks within a GxP environment for routine statistical analyses and report generation
• Use predictive models, process simulations, and forecasting techniques to enable early signal detection, proactive risk management, and optimized resource allocation
• Drive root cause analysis and develop proactive metrics using data and statistical techniques to support continuous process improvement
• Translate complex statistical findings into clear, actionable narratives through business analytics and data storytelling for executive audiences
• Mentor colleagues within and outside the department on leading-edge statistical methodologies to deliver impactful, organization-wide results
• May manage direct reports at this level
• High-level proficiency in statistical software such as JMP, Minitab, R, or SAS
• Experience with business analytics platforms such as Power BI or Tableau preferred
• Deep expertise in diverse statistical methods including multivariate regression, design of experiments, difference and equivalency testing, and control charts
• Proficiency in coding and automation of statistical analyses and dashboard reporting workflows
• Experience building and maintaining automation frameworks in a GxP environment preferred
• Strong written and oral communication skills, with demonstrated ability to present to executive audiences

This role requires:

• Master's degree in Statistics, Mathematics, or a related field
• Principal: 7+ years of relevant experience
• Staff: 9+ years of relevant experience
• May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role