Principal Biostatistician, Safety & Trials

ThermoFisher Scientific; Brussel Hoofdstad; On-site; EUR 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Principal Scientist in Biostatistics to advance life-changing therapies through rigorous statistical work. You will work in a dynamic FSP environment, designing studies, developing protocols, and delivering final analyses with regulatory-grade quality.

The role emphasizes collaboration with clients, adherence to ICH-GCP and CDISC standards, and experience in DSUR/PSUR and post-marketing analytics.

Qualifications

• Advanced degree with 6+ years of biostatistical experience in clinical research (Phase I-III).
• Expert-level proficiency in SAS programming and statistical methodology.
• Strong knowledge of ICH-GCP guidelines and clinical trial regulations.
• Demonstrated experience in statistical analysis plan development and review.
• Experience in Benefit-risk analysis, DSUR/PSUR; Post-marketing analysis, MA, RWE, and claims database.

Responsibilities

• Implement diverse statistical tasks throughout the full clinical trial process, from study design and protocol writing to final analysis and reporting.
• Collaborate with clients within a Functional Service Provider (FSP) framework and leverage the resources of Thermo Fisher Scientific.
• Contribute to advancing life-changing therapies through statistical excellence and robust evidentiary support.
• Interact with regulatory authorities as needed and ensure compliance with CDISC standards.

Skills

SAS programming

Statistics/Biostatistics

CDISC standards

Regulatory knowledge (FDA/EMA)

Team collaboration

Analytical thinking

Communication

Project management

Education

Advanced degree in Statistics/Biostatistics

Bachelor's degree + 8 years experience in biostatistics/clinical research

Tools

R

EAST

WinBUGS

SAS (also listed as skill)

Job description

Thermo Fisher Scientific is seeking a Principal Scientist in Biostatistics to advance life-changing therapies through rigorous statistical work. You will work in a dynamic FSP environment, designing studies, developing protocols, and delivering final analyses with regulatory-grade quality.

The role emphasizes collaboration with clients, adherence to ICH-GCP and CDISC standards, and experience in DSUR/PSUR and post-marketing analytics.