Senior Biostatistician: Lead Trials & Regulatory Strategy

Fortrea; Poland; On-site; PLN 180,000 - 300,000; Full time

Job summary

Fortrea is seeking a Principal Biostatistician to lead statistical strategy across complex clinical programs from design to regulatory submission and beyond.

You will partner with multidisciplinary teams to provide strategic leadership, mentor junior statisticians, and ensure high-quality analyses and reporting for global studies. Fluency in English and strong CRO/pharma experience are essential.

Qualifications

• Advanced degree (MSc/PhD) in Statistics, Biostatistics, or related field.
• Significant experience as Lead/Principal Biostatistician in CRO, biotech, or pharma.
• Strong knowledge of clinical trial statistics 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

Biostatistics

Statistical leadership

Clinical trials

Regulatory knowledge

English fluency

Education

MSc/PhD in Statistics or Biostatistics

Tools

SAS

CDISC SDTM/ADaM

Job description

Fortrea is seeking a Principal Biostatistician to lead statistical strategy across complex clinical programs from design to regulatory submission and beyond.

You will partner with multidisciplinary teams to provide strategic leadership, mentor junior statisticians, and ensure high-quality analyses and reporting for global studies. Fluency in English and strong CRO/pharma experience are essential.