Description

Principal Biostatistician – Real-World Evidence (RWE) – Global CRO – FSP Model

Remote – Canada | Mexico | United Kingdom

Are you an experienced Biostatistician with a passion for Real-World Evidence (RWE) and Real-World Data (RWD)? Join a global, high-performance team where your statistical expertise will directly impact how new therapies reach patients.

This is a remote, senior-level opportunity ideal for someone who is a Principal Statistician, although Senior II level will also be considered.

YOU MUST HAVE EXPERIENCE IN THE PHARMACEUTICAL INDUSTRY TO APPLY FOR THIS ROLE.

What You’ll Do

  • Design and execute statistical analyses using EHR, claims, registry, and observational data.
  • Lead RWE study design, including retrospective and pragmatic trials.
  • Develop and validate models using R, Python, SAS, SQL.
  • Support regulatory submissions (FDA, EMA) and communicate insights to cross-functional teams.
  • Ensure data quality, reproducibility, and compliance with global standards.

What You’ll Bring

  • PhD (5+ yrs) or MS (7+ yrs) in Statistics, Biostatistics, or related field.
  • Proven experience in RWE/RWD analytics and regulatory submissions.
  • Strong programming and data-management skills (R, Python, SAS, SQL).
  • Expertise in causal inference, survival analysis, and longitudinal data.
  • Familiarity with CDISC (SDTM, ADaM, CDASH) and ICH GCP.
  • Excellent communication, collaboration, and leadership skills.

Why Join Us

  • 100% remote with flexible schedules
  • Collaborate with global pharma and biotech leaders
  • Tailored development programs and career progression
  • Contribute to innovative therapies and meaningful healthcare outcomes
  • Great work-life balance in a stable, long-term environment

Ready to make data matter?

Apply today to lead impactful RWE studies and shape the future of evidence generation. Contact me directly at: aimee@warmanobrien.com

Keywords for Visibility

Biostatistics | Real-World Evidence | RWE | Real-World Data | RWD | Principal Biostatistician | Senior Biostatistician | Clinical Data Science | SAS | R | Python | Observational Research | Epidemiology | Causal Inference | Regulatory Submissions | Drug Development | Pharmaceutical Statistics | Healthcare Analytics | remote Biostatistician