Senior RWE Biostatistician

This is a fully remote position, open to applicants in United Kingdom, +7 more countries.

📋 Description

• Oversee the design, analysis, and interpretation of non-interventional and real-world evidence (RWE) studies using claims, electronic health records (EHR), registries, and various real-world data sources.

• Implement advanced causal inference techniques and methodologies for confounding control.

• Create and support innovative strategies for evidence generation, including target trial emulation, external control arms, and synthetic control methodologies.

• Develop and evaluate Statistical Analysis Plans, sections of statistical protocols, estimands, and study design documentation.

• Ensure compliance with relevant regulatory guidelines and RWE frameworks, aligning with FDA and EMA expectations.

• Conduct statistical quality control and promote transparency and reproducibility in analytics.

• Provide strategic, scientific, and methodological expertise to clients and project teams.

• Lead project teams responsible for statistical deliverables while offering guidance, oversight, and mentorship.

• Assist in proposal development, budgeting, bid defenses, capability presentations, and business development efforts.

• Participate in internal innovation initiatives, methodological best practices, scientific publications, and conference presentations.

• Mentor and develop junior statisticians and analysts.

• Serve as a subject matter expert in RWE methodologies and statistical best practices.

⛳️ Requirements

• An advanced degree in a relevant field such as Biostatistics, Statistics, Epidemiology, Health Economics, Data Science, Economics, Pharmacy, or a similar discipline.

• A minimum of 6 years of biostatistics experience with a Master's degree, including experience in non-interventional/RWE research, or at least 4 years with a doctoral degree.

• Demonstrated experience leading statistical activities and delivering client-focused projects in a CRO, pharmaceutical, biotechnology, healthcare, or consulting context.

• Proven expertise in applying biostatistical methods to RWE, epidemiology, and health economics outcomes research (HEOR) studies.

• Experience in utilizing claims databases, EHRs, registries, and OMOP or similar data models.

• Strong knowledge of causal inference, comparative effectiveness research, and bias-adjustment methodologies.

• Proficiency in developing Statistical Analysis Plans, contributing to protocol design, statistical analysis, and reporting.

• Programming skills in SAS and R.

• Familiarity with regulatory expectations and industry standards for RWE generation and evidence submissions.

• Experience in managing statisticians, analysts, or project teams and mentoring junior team members.

• Excellent client engagement, communication, presentation, and stakeholder management skills.

• Strong problem-solving skills, scientific curiosity, and attention to detail.

• Business proficiency in English, both spoken and written.

🏝️ Benefits

• Highly competitive compensation packages.

• Pension contributions.

• Complimentary health insurance plans.

• Remote working allowances.

• Genuine work-life balance.

• Flexibility in working hours.

• Comprehensive onboarding program with support from a personal mentor.

• Permanent employment contract with Fortrea.

• Excellent training and career development opportunities.

• Support for continuing education.

• Strong backing from Fortrea Line Manager, team, and colleagues globally.