Principal Biostatistician - Safety (FSP)

ThermoFisher Scientific; Nederland; Híbrido; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific is seeking a Principal Scientist in Biostatistics to advance life‑changing therapies through statistical excellence. You’ll lead statistical tasks across study design, analysis, and reporting within our Global Clinical Research team.

In this FSP role, collaborate with clients and internal experts, applying CDISC standards and ICH-GCP guidelines to ensure high-quality results while managing multiple trials and communicating findings clearly to stakeholders.

Qualificações

• Advanced degree in Statistics/Biostatistics or related field with substantial clinical research experience.
• Bachelor’s degree with 8 years of biostatistical experience acceptable in lieu of an advanced degree.
• Expert-level SAS programming and statistical methodology knowledge.
• Strong understanding of ICH-GCP guidelines and clinical trial regulations.
• Experience in SAP development and protocol writing is preferred.

Responsabilidades

• Lead diverse statistical tasks across the full clinical trial process from design to final analysis.
• Collaborate with clients within the FSP division and senior statisticians.
• Produce robust statistical analyses, interpretation, and reporting.
• Ensure adherence to CDISC standards and regulatory expectations across studies.

Conhecimentos

SAS programming

Statistical methods

ICH-GCP knowledge

CDISC standards

R software

WinBUGS

EAST

Analysis planning

Regulatory interaction

Trial management

Attention to detail

Communication skills

Problem solving

Formação académica

Advanced degree in Statistics/Biostatistics

Bachelor’s degree in Statistics/Biostatistics

Ferramentas

SAS

R

EAST

WinBUGS

Descrição da oferta de emprego

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.