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Senior Biostatistics Manager Rwe

8+ years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.