Principal Biostatistician

ThermoFisher Scientific; Brussel Hoofdstad; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking a Principal Scientist in Biostatistics to advance life-changing therapies through statistical excellence.

You will work within our Functional Service Provider division, applying advanced statistics across Phase I–III trials while collaborating with clients and regulatory authorities to ensure rigorous, compliant analyses and reliable trial conclusions.

Qualifications

• Advanced degree with extensive biostatistics experience in clinical trials (Ph I-III).
• Experience writing and reviewing analysis plans and statistical reports.
• Strong knowledge of ICH-GCP guidelines and regulatory expectations.

Responsabilités

• Implement diverse statistical tasks throughout the full clinical trial process.
• Contribute to study design, protocol writing, final analysis and reporting.
• Collaborate with clients within an FSP framework to enable successful trials.
• Interact with regulatory authorities and manage multiple trials concurrently.

Connaissances

SAS programming

Statistical methodology

Regulatory knowledge (ICH-GCP)

Quality and attention to detail

Strong communication skills

Multi-study management

Formation

Advanced degree in statistics/biostatistics

Bachelor's degree plus 8 years biostatistics experience

Outils

SAS

R

EAST

WinBUGS

Description du poste

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.

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


• 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.