Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you'll do meaningful work that helps make the world healthier, cleaner, and safer. Every day, our colleagues support groundbreaking scientific discoveries, accelerate the development of life-changing therapies, and help solve some of the world's most complex challenges—from improving patient outcomes to advancing cancer research and protecting public health.

We're looking for an experienced Principal Biostatistician to join our Clinical Research team. In this role, you'll play a critical part in the design, analysis, and interpretation of clinical trials that support innovative therapies and improve lives around the world.

As part of our Functional Service Provider (FSP) team, you'll work closely with pharmaceutical and biotechnology clients while benefiting from the resources, stability, and career opportunities of a global clinical research leader.

Role Overview

As a Principal Biostatistician, you will provide strategic statistical leadership across the clinical development lifecycle, including:

Leading statistical activities for Phase I–III clinical trials
Contributing to study design, protocol development, and statistical strategy
Developing and reviewing Statistical Analysis Plans (SAPs)
Overseeing statistical analyses and interpretation of study results
Supporting regulatory submissions and interactions with health authorities, including FDA and EMA
Ensuring compliance with industry standards, regulations, and best practices
Collaborating with cross-functional teams, clients, and external partners
Providing technical expertise and mentorship on biostatistical methodologies
Managing multiple studies and priorities in a dynamic clinical research environment

Required Qualifications

PhD or MS in Biostatistics, Statistics, or a related quantitative discipline
Extensive experience (typically 10+ years) in clinical research, including Phase I–III clinical trials
Experience serving in a lead biostatistics role supporting compound or program-level development
Advanced expertise in statistical methodology and SAS programming
Strong understanding of ICH-GCP guidelines and clinical trial regulations
Experience developing and reviewing Statistical Analysis Plans
Ability to effectively manage multiple studies and competing priorities
Strong analytical thinking, problem-solving, and communication skills
Excellent attention to detail and commitment to quality
Experience within a pharmaceutical company, CRO, or Functional Service Provider (FSP) environment is highly desirable.

Preferred Qualifications

Experience implementing and applying CDISC standards
Proficiency with additional statistical software such as R, EAST, or WinBUGS
Experience interacting with regulatory agencies, including FDA and EMA
Vendor management experience
Knowledge of autoimmune and/or oncology therapeutic areas

Why Join Us?

Contribute to clinical programs that have the potential to improve and save lives
Work alongside industry-leading scientists, clinicians, and researchers
Access opportunities for professional growth and career development
Collaborate in a supportive, global, and mission-driven environment
Be part of a company dedicated to advancing science and improving health worldwide

If you're passionate about applying statistical expertise to accelerate clinical development and make a meaningful impact on patients' lives, we'd love to hear from you.

Thermo Fisher Scientific

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