Lead Statistician, Early-Phase Trials (Remote)

Syneos Health; Finland (MN); On-site; USD 104,000 - 150,000; Full time

Job summary

Syneos Health is seeking a Principal Statistician for early phase work, fully home based in Europe. The role involves leading statistical activities across trials, mentoring biostatisticians, and contributing to SAPs and regulatory submissions.

The candidate should hold a PhD or MS in Biostatistics with extensive clinical trial experience, expert R and SAS skills, and strong communication in English. Prior leadership and regulatory exposure are highly valued.

Qualifications

• PhD/MS in statistics or related discipline.
• Experience leading multiple projects and programs of studies.
• Proficiency in R programming.
• Extensive knowledge of statistical design, analysis, regulatory guidelines, and programming for clinical research.
• Experience across all statistical tasks to support trials lifecycle.
• Regulatory submissions experience preferred.
• Excellent written and verbal communication in English.

Responsibilities

• Serve as a statistical department resource, mentor biostatisticians and develop training materials.
• Direct activities of other biostatistics personnel to ensure timely, high-quality work.
• Provide support across all statistical tasks from protocol to CSR.
• Prepare SAPs and collaborate with sponsor as required.
• Lead complex analyses and contribute to regulatory submissions when needed.
• Review programming specifications and CRF/database documentation.
• Ensure inspection readiness and maintain complete project documentation.
• Communicate progress and issues with management and project teams.
• Support business development activities with proposals and sponsor meetings.

Skills

R programming

SAS

Statistical design

Regulatory knowledge

English communication

Leadership

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

Job description

Syneos Health is seeking a Principal Statistician for early phase work, fully home based in Europe. The role involves leading statistical activities across trials, mentoring biostatisticians, and contributing to SAPs and regulatory submissions.

The candidate should hold a PhD or MS in Biostatistics with extensive clinical trial experience, expert R and SAS skills, and strong communication in English. Prior leadership and regulatory exposure are highly valued.