Principal Biostatistician

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

As a Principal Biostatistician at Fortrea, you will play a key role in the design, analysis, and delivery of complex clinical trials, supporting global programs from study design through to regulatory submissions and beyond. Working within our Full Service team, you will partner with multidisciplinary stakeholders and provide strategic statistical leadership to ensure high-quality, impactful outcomes.

Your 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

Your experience and 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

What you can expect from us:

• Work on complex, high-impact global studies
• Strong career development and growth opportunities
• Competitive compensation and comprehensive benefits
• Flexible, remote-friendly working environment
• Supportive, collaborative team culture

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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