Senior RWE Biostatistician

🕒 il y a 1 mois

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

🗣️🇺🇸🇬🇧 Anglais requis

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Repérée par Remote Rocketship il y a 1 mois

Toujours ouverte sur le site de Fortrea. Vérifiée il y a 3 heures.

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Fortrea

10 000+ employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Fortrea est une organisation de recherche clinique (CRO) avec plus de 30 ans d'expérience, dédiée à accélérer le développement de traitements révolutionnaires en fournissant des solutions cliniques complètes pour les entreprises de biopharmacie et MedTech. Ils offrent une gamme de services incluant la gestion des essais cliniques, les services de pharmacologie, et la stratégie réglementaire, tous conçus autour des besoins de leurs clients. La mission de Fortrea est de placer les patients au cœur de leur travail, visant à apporter des thérapies innovantes sur le marché plus rapidement grâce à des approches personnalisées et basées sur les données.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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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