Lead Biostatistician, Global Clinical Trials - Remote

Fortrea; Warszawa; Hybrid; PLN 250,000 - 420,000; Full time

Benefits offered by this job

Flexible, remote-friendly

Comprehensive benefits

Job summary

Fortrea in Warsaw, Poland seeks a Principal Biostatistician to lead strategy, design, analysis and reporting for complex global clinical trials. You will partner with multidisciplinary teams and act as the senior statistical advisor across study design, agility in submissions and regulatory interactions.

The role requires MSc/PhD in Statistics or Biostatistics, extensive CRO/pharma leadership, SAS expertise with CDISC SDTM/ADaM, and fluent English.

Qualifications

• Advanced degree (MSc/PhD) in Statistics, Biostatistics, or related field.
• Significant experience as a Lead/Principal Biostatistician in CRO, biotech, or pharma.
• Strong knowledge of statistical methods for clinical trials and regulatory requirements (FDA/EMA).
• Proficiency in SAS (including advanced procedures).
• Solid experience with CDISC standards (SDTM, ADaM, TFLs).
• Ability to communicate complex statistical concepts to diverse stakeholders.
• Strong organizational skills, attention to detail, and collaborative mindset.
• Fluent in English.

Responsibilities

• Lead statistical strategy and delivery for complex studies and programs (including submissions and multi-protocol work)
• Develop and review Statistical Analysis Plans and ensure quality of statistical outputs
• Provide oversight of statistical analyses, Tables, Figures & Listings (TFLs), and study reporting
• Collaborate closely with cross-functional teams and act as a key statistical advisor
• Support regulatory interactions, publications, and post hoc analyses
• Contribute to study design, protocols, and randomization planning
• Mentor junior statisticians and provide technical leadership
• Represent Biostatistics in client interactions, bid defenses, and audits

Skills

SAS programming

CDISC SDTM/ADaM

Statistical leadership

Regulatory knowledge

English fluency

Stakeholder communication

Mentoring

Education

MSc/PhD in Statistics/Biostatistics

Tools

SAS (advanced procedures)

Job description

Fortrea in Warsaw, Poland seeks a Principal Biostatistician to lead strategy, design, analysis and reporting for complex global clinical trials. You will partner with multidisciplinary teams and act as the senior statistical advisor across study design, agility in submissions and regulatory interactions.

The role requires MSc/PhD in Statistics or Biostatistics, extensive CRO/pharma leadership, SAS expertise with CDISC SDTM/ADaM, and fluent English.