Principal Biostatistician: Clinical Trials Lead & Analytics

Cytel; Columbus (OH); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I‑IV clinical studies across the region. You will provide statistical leadership, design, and analysis plans, and collaborate with sponsors and cross‑functional teams to drive regulatory submissions.

You will apply advanced modeling, simulations, and ISS/ISE support, while mentoring teams and ensuring high‑quality, timely deliverables in a fast-paced environment.

Qualifications

• Master's degree in Statistics, Biostatistics, or a related discipline; PhD strongly preferred.
• 8–10 years of biostatistics experience supporting clinical trials in pharma/biotech; CRO experience preferred.
• 3–5 years of Study Lead experience with cross-functional teams.
• Experience in study design, SAP development, ISS/ISE, and regulatory submissions.

Responsibilities

• Develop study protocols, design discussions, and sample size calculations.
• Perform exploratory analyses to inform decisions and generate insights.
• 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 endpoints.
• Review CRFs, develop SAPs, and specify analysis datasets.
• Communicate statistical methodology clearly to technical and non‑technical audiences.
• Collaborate across teams and adapt to changing priorities.

Skills

R

SAS

Study Lead

Advanced statistics

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

ADaM

Job description

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I‑IV clinical studies across the region. You will provide statistical leadership, design, and analysis plans, and collaborate with sponsors and cross‑functional teams to drive regulatory submissions.

You will apply advanced modeling, simulations, and ISS/ISE support, while mentoring teams and ensuring high‑quality, timely deliverables in a fast-paced environment.