Senior Real World Data Statistician

Alexion

Unknown
Statistical analyses of registry data
Regulatory-grade real-world evidence
Survival and longitudinal modeling
You will craft regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfill post-market commitments

Job Summary

  • You will craft regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfill post-market commitments.
  • Joining our growing epidemiology and real-world evidence capability, you will apply statistical methodologies tailored for registries, align to AstraZeneca standards, and contribute to a portfolio that demands rigor, creativity, and impact.
  • We balance the expectation of being in the office while respecting individual flexibility, working a minimum of three days per week from the office.

Matching Summary

You will craft regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfill post-market commitments.

Skills & Requirements

Must-have

  • statistical analyses of registry data
  • regulatory-grade real-world evidence
  • survival and longitudinal modeling
  • propensity score and causal inference
  • compliance with FDA and EMA guidelines
  • collaboration with clinical and regulatory teams

Nice-to-have

  • experience with rare disease programs
  • peer-reviewed publications or presentations
  • strong communication and influence skills
  • flexible in-office work arrangement
  • methodological innovation in registries

Key Requirements

  • Advanced degree in statistics or related field
  • Proficiency with R and/or SAS
  • Understanding of SQL or Python
  • Experience with regulatory submissions
  • Knowledge of FDA RWE Framework and EMA guidance
  • Experience in rare disease real-world evidence
  • Ability to support regulatory advisory meetings

Work Rights

Not specified

Tailored Resume

Cover Letter