Remote Principal Biostatistician — RWE & RWD

Warman O'Brien; Polska; Remote; PLN 466,000 - 700,000; Full time

Benefits offered by this job

Remote work

Flexible schedules

Global collaboration

Career progression

Exposure to regulatory submissions

Job summary

Warman O'Brien is seeking a Principal Biostatistician – Real-World Evidence (RWE) for a remote, senior-level engagement within a global CRO. You will lead non-interventional studies using real-world data, and develop RWE models in R, Python, SAS and SQL, while supporting regulatory submissions to FDA/EMA.

Ideal candidates hold a PhD (5+ years) or MS (7+ years) in statistics or biostatistics, with pharma RWE experience and strong leadership and communication skills.

Qualifications

• 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 with 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.

Responsibilities

• non-interventional study methodology and statistics using real world data
• 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.

Skills

RWE analytics

Regulatory submissions

Programming skills

Communication

Leadership

Collaboration

Education

PhD in Statistics

MS in Biostatistics

Tools

R

Python

SAS

SQL

Job description

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

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

• non-interventional study methodology and statistics using real world data
• 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: [e-mail]

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