Principal Biostatistician – Safety

🔥 1 minute ago

🌐 United Kingdom, Belgium, +6 more countries – Remote

🇬🇧 United Kingdom – Remote 🇧🇪 Belgium – Remote 🇬🇷 Greece – Remote 🇫🇷 France – Remote 🇭🇺 Hungary – Remote 🇳🇱 Netherlands – Remote 🇮🇹 Italy – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Contribute to advancing life-changing therapies through statistical excellence • Work closely with clients as part of the Functional Service Provider (FSP) division • 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 • Contribute to clinical research programmes and generate scientific evidence to understand treatments and improve patient 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 • Demonstrated experience in Benefit-risk analysis, Safety reporting DSUR, PSUR; Post-marketing analysis, MA, RWE, claims database • 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 • Full-time employment

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