Principal Biostatistician

🔥 3 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Implement diverse statistical tasks throughout the full clinical trial process • Contribute to study design and protocol writing • Develop and review statistical analysis plans • Perform final clinical trial analysis and reporting • Work closely with clients as part of the Functional Service Provider (FSP) division • Support advanced clinical development programs • Interact with regulatory authorities including FDA and EMA • Manage multiple clinical trials simultaneously • Collaborate with clinical research teams and vendors

🎯 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 • Access to Thermo Fisher Scientific resources and career development opportunities • Opportunity to work with advanced clinical development programs • Opportunity to contribute to life-changing therapies and global health outcomes

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