Principal Biostatistician; RWE, HEOR - North America, Europe

Updated: October 23, 2025
Location: USA-SC-Remote
Job :

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We are looking for a Principal Biostatistician to lead RWE and HEOR projects across North America and Europe. The analyst will collaborate with cross‑functional teams, mentor biostatisticians, and design and oversee statistical analyses for regulatory and commercialization purposes.

• Passionate about developing people with career development, supportive line management, and reward systems.
• Committed to a Total Self culture where you can authentically be yourself.
• Strive to build a company everyone wants to work for, valuing diversity and belonging.

• Experience with RWD including eHR, registry studies, pharmacy data, and clinical trial data.
• Experience with real‑world safety studies and healthcare claims analysis.
• Design and implement statistical methods: propensity score matching, estimands, logistic regression, survival analysis, incident rate models.
• Conduct safety assessments: disproportionality analyses, surveillance methods, safety risk modeling, data mining, AI/ML, signal detection.
• Prepare Statistical Analysis Plans (SAPs) and mock‑up displays for tables, listings, and figures.
• Review SAS annotated CRFs, database design, and study documentation.
• Develop programming specifications for analysis datasets, tables, listings, and figures.
• Direct and review work of biostatistics personnel, ensuring high‑quality outputs.
• Provide statistical programming support and quality control of project deliverables.
• Participate in DSMBs/DMCs as independent or voting statistician.
• Lead integrated analyses and attend regulatory agency meetings as needed.
• Maintain project documentation and ensure inspection readiness.
• Support business development activities and proposals.
• Adapt to changing timelines and manage scheduling across multiple projects.
• Communicate statistical concepts effectively to cross‑functional teams.

• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials; proven ability to lead multiple projects and programs.
• Proficiency in programming (SAS, R, or other statistical software).
• Strong knowledge of statistical design, analysis, and regulatory guidelines.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills.
• Fluency in English (reading, writing, speaking).

• Company car or car allowance.
• Health benefits:
  
  Medical, Dental, Vision.
• 401(k) company match.
• Eligibility to participate in Employee Stock Purchase Plan.
• Opportunity to earn commissions/bonus.
• Flexible paid time off (PTO) and sick time.
• Compliance with all applicable paid sick time requirements.

$95,000.00 – $ (base salary; actual will vary by qualifications and experience).

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. We provide reasonable accommodations for applicants with disabilities.

Phone: 919 876 9300
Fax: 919 876 9360
Website:
Email:

Tasks, duties, and responsibilities are not exhaustive. The Company reserves the right to assign additional tasks as needed.