Senior Principal Biostatistician, Clinical Trials Lead

Cytel; Dover (DE); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Cytel Inc. is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the region, applying advanced statistics, modeling and simulation to inform development plans and regulatory strategies.

You will design studies, SAPs, ISS/ISEs, review CRFs, and provide strategic statistical guidance to cross-functional teams. Strong R and SAS skills, CDISC, ICH knowledge, and excellent communication are essential.

Qualifications

• 8–10 years of biostatistics experience in pharma/biotech.
• Experience leading studies with cross-functional development teams.
• Strong knowledge of ICH guidelines and CDISC standards.
• Experience with ISS/ISE regulatory submissions is a plus.

Responsibilities

• Provide statistical support across Phase I–IV trials.
• Develop and oversee SAPs, ISS/ISE analyses.
• Lead exploratory analyses and efficacy analyses.
• Design studies, sample size calculations, and simulation studies.
• Communicate statistical methodology to non‑technical audiences.
• Collaborate with cross-functional teams and vendors.

Skills

Biostatistics expertise

R programming

SAS programming

Study lead experience

ICH and CDISC knowledge

Cross-functional collaboration

Excellent communication

Education

Master's degree in Statistics/Biostatistics

PhD strongly preferred

Tools

R

SAS

Job description

Cytel Inc. is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the region, applying advanced statistics, modeling and simulation to inform development plans and regulatory strategies.

You will design studies, SAPs, ISS/ISEs, review CRFs, and provide strategic statistical guidance to cross-functional teams. Strong R and SAS skills, CDISC, ICH knowledge, and excellent communication are essential.