Senior Biostatistician – Lead Clinical Trials

Cytel; Columbus (OH); On-site; USD 130,000 - 210,000; Full time

Job summary

Cytel is seeking a Principal Biostatistician to lead statistical support for one or more client trials, spanning Phase I–IV. You will influence study design, SAPs, ISS/ISE, and integrated summaries, applying advanced methods and simulation to optimize decisions.

You will work closely with cross‑functional teams, communicate complex statistics in plain language, and drive high-quality analyses under tight timelines.

Qualifications

• Experience leading Phase I–IV clinical studies.
• 8–10 years biostatistics experience in pharma/biotech.
• CRO experience strongly preferred.
• 3–5 years of Study Lead experience.

Responsibilities

• Participate in study design discussions and sample size calculations.
• Perform exploratory data analyses to evaluate trends and support decision-making.
• Apply advanced statistical methods including mixed models and longitudinal analyses.
• Design and execute simulation studies to evaluate designs and methods.
• Lead efficacy analyses and interpretation of primary/secondary endpoints.
• Review CRFs; develop SAPs and ISS/ISE related documents.
• Perform statistical analyses and interpret results.
• Provide strategic statistical guidance to cross-functional teams.
• Present methodology and implications clearly to non-technical audiences.
• Collaborate effectively to meet project goals and timelines.
• Adapt to changing priorities in a dynamic environment.

Skills

Clinical study leadership

Cross-functional collaboration

Statistical modeling

Machine learning basics

Communication skills

Ambiguity management

Timeline management

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

Job description

Cytel is seeking a Principal Biostatistician to lead statistical support for one or more client trials, spanning Phase I–IV. You will influence study design, SAPs, ISS/ISE, and integrated summaries, applying advanced methods and simulation to optimize decisions.

You will work closely with cross‑functional teams, communicate complex statistics in plain language, and drive high-quality analyses under tight timelines.