Summary

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.

Job 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

Company overview

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.