Principal Biostatistician - Safety (FSP)

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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

About the Opportunity

You will have the opportunity to support an innovative, science-driven global biotechnology company focused on developing transformative therapies for people living with severe autoimmune diseases.

Working in a dynamic and collaborative environment, you will contribute to a growing portfolio of clinical research programmes, helping generate the scientific evidence needed to better understand treatments and improve patient outcomes.

This is an exciting opportunity to apply your statistical expertise within a highly innovative therapeutic area, collaborate with leading scientific experts and play a key role in advancing research with the potential to make a meaningful difference in patients' lives.

DESCRIPTION:

Join our Clinical Research team as a Principal Scientist in Biostatistics, where you'll contribute to advancing life-changing therapies through statistical excellence. As part of our Functional Service Provider (FSP) division, you'll work closely with clients while utilizing the benefits and resources of an established leader in clinical research. You'll be responsible for implementing diverse statistical tasks throughout the full clinical trial process, from study design and protocol writing to final analysis and reporting. This position offers the opportunity to impact health outcomes while working with advanced clinical development programs.

REQUIREMENTS:

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in biostatistical experience in clinical research, with emphasis on Phase I-III trials
• Preferred Fields of Study: Statistics, Biostatistics, or related quantitative field
• 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
• Demonstrated experience in Benefit-risk analysis, Safety reporting DSUR, PSUR; Post-marketing analysis, MA, RWE, claims database
• Ability to manage multiple clinical trials simultaneously
• Advanced knowledge of CDISC standards and their implementation
• Experience with statistical software packages such as R, EAST, or WinBUGS
• Strong analytical and problem-solving skills
• Excellence in written and verbal communication
• Ability to interact effectively with regulatory authorities (FDA, EMA)
• Experience in CRO environment and vendor management preferred
• Knowledge of auto-immune and/or oncology therapeutic areas beneficial
• Demonstrated ability to work collaboratively in teams
• Ability to meet deadlines and manage competing priorities
• Strong attention to detail and quality focus

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.