Principal Biostatistician
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Job Description
Principal Biostatistician supporting Thermo Fisher Scientific’s clinical research programs. Applying SAS, CDISC, and statistical methodology from study design through final reporting.
Responsibilities:
- Contribute to advancing life-changing therapies through statistical excellence
- Work as part of the Clinical Research team in the Functional Service Provider (FSP) division
- Work closely with clients while utilizing the resources of an established clinical research leader
- Implement diverse statistical tasks throughout the full clinical trial process
- Contribute to study design and protocol writing
- Perform final analysis and reporting
- Support advanced clinical development programs and impact health outcomes
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
Benefits:
- Fully remote work arrangement
- Standard Monday–Friday work schedule
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