Principal Biostatistician

Description:

Warman O’Brien, in partnership with a leading global Contract Research Organization (CRO), is seeking a Principal Biostatistician – Real-World Evidence (RWE) to join their expanding Functional Service Provider (FSP) team. This is an exciting fully remote opportunity based in Canada for a highly skilled biostatistician passionate about leveraging real-world data to drive impactful decisions in regulatory, clinical, and commercial contexts.

As a Principal Biostatistician, you will lead complex analytical initiatives using cutting-edge real-world datasets such as electronic health records (EHRs), insurance claims, and patient registries. You will play a pivotal role in shaping RWE strategies, ensuring statistical rigor, and generating insights that support the development and market success of innovative therapies.

Key Responsibilities:

• Source, access, and manage diverse real-world datasets (EHRs, claims, registries, etc.).

• Design and optimize data pipelines while ensuring compliance and high data quality.

• Lead advanced statistical analyses including causal inference, propensity score matching, survival analysis, and machine learning-based modeling.

• Deliver comparative effectiveness, pharmacoeconomic, and patient outcomes studies.

• Develop and author study protocols, statistical analysis plans (SAPs), and regulatory-aligned documentation.

• Prepare detailed technical reports, visualizations, and manuscripts for internal and external audiences.

• Provide strategic statistical guidance throughout drug development and market access initiatives.

• Promote data integrity, reproducibility, and validation best practices within the organization.

Required Skills & Qualifications:

• PhD in Biostatistics, Statistics, or related discipline, or MSc with 5+ years of relevant experience.

• In-depth understanding of real-world evidence methodologies and applications.

• Expertise in statistical programming (R, Python, SAS) and data visualization tools (Power BI, Tableau, Shiny).

• Familiarity with FDA and EMA RWE frameworks and industry standards (ISPOR, ISPE, CDISC).

• Strong communication and leadership skills, with the ability to translate technical findings into actionable insights for diverse stakeholders.

• Ability to work independently in a fully remote, fast-paced, global environment.

About the Organization:

Warman O’Brien is a specialized life sciences recruitment consultancy partnering with leading pharmaceutical, biotech, and CRO organizations across North America and beyond. This particular opportunity is with a top-tier global CRO focused on advancing real-world data analytics to accelerate access to safe and effective therapies worldwide.

The company values innovation, scientific integrity, and collaboration, offering its employees the chance to make a measurable impact on healthcare outcomes while working remotely with global experts.