Principal Biostatistician - Lead Global Clinical Trials

Cytel; Denver (CO); On-site; USD 160,000 - 230,000; Full time

Job summary

Cytel Inc. seeks a Principal Biostatistician to lead Phase I–IV clinical studies across the region, applying advanced statistical methods and simulations to inform development decisions.

You will guide study design, SAPs, ISS/ISE and collaborate with cross-functional teams for regulatory success. Ideal candidates have 8–10 years in biostatistics in pharma/biotech, strong R and SAS skills, and proven leadership with tight timelines.

Qualifications

• 8–10 years of biostatistics experience in pharma/biotech.
• 3–5 years of Study Lead experience with cross-functional teams.
• Strong knowledge of ICH guidelines and CDISC standards.
• Experience with ISS/ISE regulatory submissions.

Responsibilities

• Lead statistical analyses and interpretation for Phase I–IV trials.
• Develop SAPs, analysis datasets and TLF specifications.
• Design and evaluate study designs, sample sizes and simulations.
• Collaborate with cross-functional teams and external vendors.

Skills

Biostatistics

Clinical trials

Statistical modeling

Data analysis

Communication skills

Leadership

Education

Master's degree in Statistics or Biostatistics

PhD preferred

Tools

R

SAS

Job description

Cytel Inc. seeks a Principal Biostatistician to lead Phase I–IV clinical studies across the region, applying advanced statistical methods and simulations to inform development decisions.

You will guide study design, SAPs, ISS/ISE and collaborate with cross-functional teams for regulatory success. Ideal candidates have 8–10 years in biostatistics in pharma/biotech, strong R and SAS skills, and proven leadership with tight timelines.