Principal Biostatistician: Lead Clinical Trials & Analytics

Cytel; Des Moines (IA); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead one Phase I–IV clinical study across the region. You will provide statistical development support, oversee integrated analyses, and guide cross‑functional teams while collaborating with client sponsors.

You will design studies, perform complex modeling, run simulations, and contribute to regulatory submissions. Strong R/SAS skills, CDISC standards, and regulatory experience are required.

Qualifications

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

Responsibilities

• Participate in study protocol development including design discussions and sample size.
• Lead exploratory analyses to guide scientific decisions and insights.
• Apply advanced statistical methods for efficacy 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 specify analysis datasets.
• Provide strategic statistical guidance to cross‑functional teams.
• Communicate assumptions and implications of statistical decisions clearly.

Skills

Statistical methods

Mixed models

Longitudinal analyses

Simulation

Education

Master's degree in Statistics/Biostatistics or related

PhD strongly preferred

Tools

R

SAS

CDISC

Job description

Cytel is seeking an experienced Principal Biostatistician to lead one Phase I–IV clinical study across the region. You will provide statistical development support, oversee integrated analyses, and guide cross‑functional teams while collaborating with client sponsors.

You will design studies, perform complex modeling, run simulations, and contribute to regulatory submissions. Strong R/SAS skills, CDISC standards, and regulatory experience are required.