Job Title: Senior Biostatistics Manager – Real-World Evidence (RWE)
Location: Durham, United States
Category: Clinical
Job Type: Full-Time
Work Mode: Remote or Hybrid (as applicable with Fortrea policy)
Job Summary:
Fortrea, a global leader in clinical research and consulting, is seeking a Senior Biostatistics Manager – RWE to lead complex real-world evidence (RWE) studies. In this pivotal role, you’ll oversee the development of statistical analysis plans (SAPs), provide programming oversight, and support post-market regulatory submissions and publications for top pharmaceutical and biotech clients.
Key Responsibilities:
Lead complex RWE studies or multi-protocol programs across various locations
Develop and review advanced Statistical Analysis Plans (SAPs)
Oversee and review statistical outputs including Tables, Figures, and Listings (TFLs)
Draft and contribute to statistical sections of study protocols
Participate in bid defense and client meetings
Present findings at internal and external scientific forums
Act as Subject Matter Expert on biostatistics and RWE methodologies
Contribute to the development or review of procedural documents
Required Skills & Qualifications:
Doctoral degree preferred in biostatistics, computer science, or related field
Minimum 8 years of experience as a Lead Biostatistician in CRO, biotech, or pharma industry
Strong proficiency in SAS® programming and statistical analysis methods
Experience with SDTM, ADaM datasets, and clinical TFLs
Excellent written and verbal communication of statistical concepts
Deep understanding of observational/RWE study design and analytics
Demonstrated ability to lead projects independently with organizational efficiency
Experience developing and reviewing SAPs for complex study designs
Perks & Benefits:
Highly competitive compensation and benefits package
Remote work flexibility and adjustable working hours
Pension contributions and health insurance
Remote work allowance
Structured onboarding with dedicated mentorship
Permanent employment with career advancement support
Access to training, certifications, and continuous learning programs
Company Description:
Fortrea is a global contract research and consulting organization with a proven track record in delivering scientific, statistical, and regulatory excellence across real-world evidence, clinical trials, and biopharma consulting. We offer a collaborative environment driven by innovation, quality, and impact on global health outcomes.
Work Mode: Remote or Hybrid (as per Fortrea’s policy)
Call-to-Action:
Ready to lead impactful RWE studies with a globally respected team? Apply today to join Fortrea as a Senior Biostatistics Manager and elevate your career in clinical analytics and pharmaceutical research.
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