Senior Biostatistician - Clinical Trials & Analysis Leader

Cytel; Providence (RI); On-site; USD 180,000 - 240,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies in collaboration with client teams and Cytel support. You will shape statistical methodologies, designs, and analyses across trials, including safety and efficacy endpoints.

Ideally, you bring 8–10 years of biostatistics experience, strong R and SAS skills, and a track record in regulatory submissions. This role emphasizes leadership, collaboration, and high-quality delivery under tight

Qualifications

• Master's degree in Statistics or Biostatistics (PhD preferred).
• 8–10 years of biostatistics experience in clinical trials (pharma/biotech).
• 3–5 years Study Lead experience with cross-functional teams.
• Strong knowledge of advanced statistical methods (mixed models, longitudinal analyses).
• CDISC standards and regulatory submission experience (ISS/ISE) desired.

Responsibilities

• Participate in development of study protocols and design discussions.
• Lead efficacy analyses and interpretation of endpoints.
• Review CRFs and develop SAPs with analysis datasets.
• Perform statistical analyses and communicate results clearly to stakeholders.
• Lead project activities and provide strategic statistical guidance to teams.
• Ensure compliance with ICH guidelines and regulatory expectations.

Skills

Statistical modeling

R programming

SAS programming

Data visualization

Cross-functional leadership

Regulatory communication

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

Job description

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies in collaboration with client teams and Cytel support. You will shape statistical methodologies, designs, and analyses across trials, including safety and efficacy endpoints.

Ideally, you bring 8–10 years of biostatistics experience, strong R and SAS skills, and a track record in regulatory submissions. This role emphasizes leadership, collaboration, and high-quality delivery under tight