Senior RWE Biostatistician

🕒 September 16

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

🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote 🇸🇰 Slovakia – Remote 🇧🇬 Bulgaria – Remote 🇪🇪 Estonia – Remote 🇬🇷 Greece – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 23%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Lead the design, analysis, and interpretation of non-interventional and RWE studies utilizing claims, EHR, registry, and other real-world data sources • Apply advanced causal inference and confounding-control methodologies • Design and support innovative evidence-generation strategies, including target trial emulation, external control arms, and synthetic control methodologies • Develop and review Statistical Analysis Plans, statistical protocol sections, estimands, and study design documentation • Ensure alignment with applicable regulatory guidance and RWE frameworks, including FDA and EMA expectations • Perform statistical quality control and promote analytic reproducibility and transparency • Deliver strategic, scientific, and methodological expertise to clients and project teams • Manage project teams responsible for statistical deliverables while providing guidance, oversight, and mentorship • Support proposal development, budgeting, bid defenses, capability presentations, and business development activities • Contribute to internal innovation initiatives, methodological best practices, scientific publications, and conference presentations • Mentor and develop junior statisticians and analysts • Act as a subject matter expert for RWE methodologies and statistical best practices

🎯 Requirements

• Advanced degree in a relevant discipline such as Biostatistics, Statistics, Epidemiology, Health Economics, Data Science, Economics, Pharmacy, or a related field • Minimum of 6 years of biostatistics experience with a Master's degree, including non-interventional/RWE research experience, or at least 4 years with a doctoral degree • Proven experience leading statistical activities and delivering client-facing projects within a CRO, pharmaceutical, biotechnology, healthcare, or consulting environment • Demonstrated expertise in applying biostatistical methods to RWE, epidemiology, and HEOR studies • Experience utilizing claims databases, EHRs, registries, and OMOP or similar data models • Strong understanding of causal inference, comparative effectiveness research, and bias-adjustment methodologies • Experience developing SAPs, contributing to protocol design, statistical analysis, and reporting • Programming proficiency in SAS and R • Knowledge of regulatory expectations and industry standards for RWE generation and evidence submissions • Experience managing statisticians, analysts, or project teams and mentoring less experienced team members • Strong client engagement, communication, presentation, and stakeholder management skills • Excellent problem-solving ability, scientific curiosity, and attention to detail • Business fluency in English, both verbal and written

🏖️ Benefits

• Highly competitive compensation packages • Pension contributions • Complimentary health insurance plans • Remote working allowances • Genuine work-life balance • Flexibility in working hours • Thorough onboarding program with support from a personal mentor • Permanent employment contract with Fortrea • Excellent training and career development opportunities • Support for continuing education • Strong support from Fortrea Line Manager, team, and colleagues worldwide

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