Senior Principal Biostatistician — Lead Global Trials

Cytel; Juneau (AK); On-site; USD 180,000 - 240,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the region. You will be embedded with a pharmaceutical client, influencing study design, SAPs, ISS/ISE, and regulatory submissions while guiding teammates.

You will apply advanced statistical methods using R and SAS, communicating complex concepts to non-technical stakeholders and driving cross-functional initiatives in a fast-paced environment.

Qualifications

• Master's degree in Statistics or Biostatistics required; PhD preferred.
• 8–10 years of biostatistics experience in pharma/biotech; CRO experience valued.
• 3–5 years of Study Lead experience with cross-functional teams.
• Strong knowledge of mixed models, longitudinal analyses, and simulations.
• Proficient in R and SAS; GxP regulatory submissions knowledge; CDISC.

Responsibilities

• Lead statistical strategy and analyses for Phase I–IV trials.
• Develop SAPs, analysis datasets, and ISS/ISE reports.
• Oversee design, sample size, and regulatory submissions.
• Collaborate with cross-functional teams and present methods clearly.
• Mentor junior statisticians and ensure timely delivery.

Skills

Study design

Sample size calculations

R

SAS

Cross-functional leadership

Regulatory submissions

Education

Master's degree in Statistics/Biostatistics

PhD strongly preferred

Tools

R (statistical software)

SAS (Programming)

CDISC standards

ISS/ISE experience

Job description

Cytel is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the region. You will be embedded with a pharmaceutical client, influencing study design, SAPs, ISS/ISE, and regulatory submissions while guiding teammates.

You will apply advanced statistical methods using R and SAS, communicating complex concepts to non-technical stakeholders and driving cross-functional initiatives in a fast-paced environment.