Principal Biostatistician (FSP - client embedded)
Thermo Fisher Scientific
Principal Scientist in Biostatistics supporting clinical research and drug development at a contract research organization. Responsible for statistical design, analysis, and reporting across Phase I-III trials while collaborating with clients and internal teams.
Responsibilities
- Implement statistical tasks across clinical trial lifecycle from design through final analysis
- Develop and review statistical analysis plans for study protocols
- Conduct statistical analyses and prepare regulatory reports for clinical trials
- Manage multiple concurrent clinical development programs and competing priorities
- Collaborate with clients, internal teams, and regulatory authorities on trial strategy
Requirements
- Advanced degree plus 6 years or Bachelor's degree plus 8 years biostatistics experience in clinical trials
- Expert-level SAS programming and statistical methodology expertise
- Strong ICH-GCP guidelines and clinical trial regulations knowledge
- Demonstrated statistical analysis plan development and review experience
- Advanced CDISC standards implementation knowledge
- Proficiency with R, EAST, or WinBUGS statistical software
- Ability to interact with regulatory authorities and manage multiple concurrent trials
L'offre d'emploi a été publiée 1 Il y a un mois
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