Principal Biostatistician; RWE, HEOR - North America, Europe

Job Details

Location: USA-VA-Remote

Job :

Updated: October 23, 2025

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success by translating clinical, medical, and commercial insights into outcomes.

Principal Biostatistician (RWE, HEOR) – North America, Europe. Responsible for the statistical aspects of clinical development, including real‑world evidence and health‑economics and outcomes research.

• Experience with a variety of real‑world data (eHR, registry studies, pharmacy data, etc.) and clinical trial data.
• Experience with real‑world safety studies, including healthcare claims knowledge.
• Apply propensity‑score matching, estimands, logistic regression, survival analysis, incident‑rate models.
• Safety assessment skills: disproportionality analyses, statistical surveillance, safety risk modeling, data mining, AI/ML, signal detection.
• Develop and review Statistical Analysis Plans (SAPs) and programming specifications for analysis datasets.
• Generate randomization schedules and contribute to clinical study reports.
• Collaborate with sponsor and study teams; provide independent review of statistical work.
• Lead integrated analyses; attend regulatory agency meetings as needed.
• Maintain well‑organized documentation and ensure inspection readiness.
• Support business‑development activities and proposals where appropriate.
• Provide statistical programming support and, when required, serve on DSMBs/DMCs.

• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials or equivalent combination of education and experience.
• Proficiency in programming (SAS preferred).
• Strong knowledge of statistical design, analysis, regulatory guidelines, and programming techniques.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills; fluent in English.
• Ability to read, write, speak, and understand English.
• Minimal travel may be required.

Legal compliance:
Equal Opportunity Employer. Requested information for applicants with disabilities will be provided. All qualified applicants will receive consideration regardless of race, color, age, religion, marital status, ethnicity, gender identity, sexual orientation, veteran, or disability status.

Salary Range: $95,000 – $175,700. Benefits may include health, dental, vision, 401(k) match, Employee Stock Purchase Plan, commissions/bonus, paid time off, and more (subject to state regulations).

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