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.
As a Principal Biostatistician, you will provide strategic statistical leadership across the clinical development lifecycle, including:
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Leading statistical activities for Phase I–III clinical trials
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Contributing to study design, protocol development, and statistical strategy
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Developing and reviewing Statistical Analysis Plans (SAPs)
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Overseeing statistical analyses and interpretation of study results
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Supporting regulatory submissions and interactions with health authorities, including FDA and EMA
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Ensuring compliance with industry standards, regulations, and best practices
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Collaborating with cross-functional teams, clients, and external partners
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Providing technical expertise and mentorship on biostatistical methodologies
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Managing multiple studies and priorities in a dynamic clinical research environment
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PhD or MS in Biostatistics, Statistics, or a related quantitative discipline
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Extensive experience (typically 10+ years) in clinical research, including Phase I–III clinical trials
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Experience serving in a lead biostatistics role supporting compound or program-level development
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Advanced expertise in statistical methodology and SAS programming
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Strong understanding of ICH-GCP guidelines and clinical trial regulations
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Experience developing and reviewing Statistical Analysis Plans
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Ability to effectively manage multiple studies and competing priorities
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Strong analytical thinking, problem-solving, and communication skills
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Excellent attention to detail and commitment to quality
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Experience within a pharmaceutical company, CRO, or Functional Service Provider (FSP) environment is highly desirable.
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Experience implementing and applying CDISC standards
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Proficiency with additional statistical software such as R, EAST, or WinBUGS
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Experience interacting with regulatory agencies, including FDA and EMA
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Vendor management experience
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Knowledge of autoimmune and/or oncology therapeutic areas
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Contribute to clinical programs that have the potential to improve and save lives
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Work alongside industry-leading scientists, clinicians, and researchers
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Access opportunities for professional growth and career development
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Collaborate in a supportive, global, and mission-driven environment
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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.
