Principal Biostatistician, Clinical Trials Leader

Cytel; Honolulu (HI); On-site; USD 160,000 - 220,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead statistical support across Phase I–IV clinical trials within our client partnerships. You will design studies, develop SAPs, and guide regulatory submissions while collaborating with cross-functional teams to translate complex statistics into actionable decisions.

Your expertise in R, SAS, CDISC, and ISS/ISE will drive statistical excellence and innovation in a fast-paced environment.

Qualifications

• 8–10 years biostatistics experience in pharma/biotech.
• 3–5 years of Study Lead experience.
• Experience with study design, SAP, ISS/ISE, and regulatory submissions.

Responsibilities

• Lead statistical analyses for Phase I–IV trials and provide strategic guidance.
• Develop and review SAPs, analysis datasets, and ISS/ISE documents.
• Perform exploratory analyses to support decision-making and trial design.
• Design and evaluate complex modeling and simulation studies.
• Collaborate with cross-functional teams and communicate statistical methods clearly.
• Review CRFs and data review guidelines; ensure regulatory compliance.

Skills

R programming

SAS programming

Statistical modeling

Clinical trial analysis

Study Lead

Regulatory submissions

Communication skills

Cross-functional collaboration

CDISC standards

ISS/ISE

Education

Master's degree in Statistics/Biostatistics

PhD (preferred)

Tools

R

SAS

Job description

Cytel is seeking an experienced Principal Biostatistician to lead statistical support across Phase I–IV clinical trials within our client partnerships. You will design studies, develop SAPs, and guide regulatory submissions while collaborating with cross-functional teams to translate complex statistics into actionable decisions.

Your expertise in R, SAS, CDISC, and ISS/ISE will drive statistical excellence and innovation in a fast-paced environment.