Principal Biostatistician – FSP Europe
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Belgium
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Job Level
Tech Stack
About the role
- Join our Clinical Research team as a Principal Scientist in Biostatistics
- Contribute to advancing life-changing therapies through statistical excellence
- Work closely with clients while utilizing the benefits and resources of Thermo Fisher Scientific
- Responsible for implementing diverse statistical tasks throughout the full clinical trial process, from study design and protocol writing to final analysis and reporting
- 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
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
SAS programmingstatistical methodologystatistical analysis plan developmentCDISC standardsstatistical software packagesREASTWinBUGSclinical trial processstudy design
Soft Skills
analytical skillsproblem-solving skillswritten communicationverbal communicationcollaborative skillsattention to detailquality focustime managementability to manage multiple trialsinterpersonal skills
Certifications
Ph.D. in BiostatisticsMS in Biostatistics