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Principal Biostatistician - FSP Europe
Thermo Fisher Scientific —Remote
- Full-time
- Remote
- Doctoral degree
- Master's degree
- Analysis skills
Principal Statistician Oncology with Submission Experience
Syneos - Clinical and Corporate - Prod —Remote
- Full-time
- Remote
- English
- Travel
- Contracts
2d

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Principal Statistician Oncology with Submission Experience
Syneos - Clinical and Corporate - Prod —Remote
May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an…
2d

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Principal Biostatistician - FSP Europe

Thermo Fisher Scientific -
Remote

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Job details

Full-time

Qualifications

Statistical software
Clinical research
Doctoral degree
SAS
R
Master's degree
Statistical analysis
Analysis skills
Communication skills
FDA regulations

Full job description

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:

Ph. D or MS Biostatistics Degree plus minimum 10 years of experience in clinical research, with emphasis on Phase I-III trials with compound Lead level experience
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

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