Principal Biostatistician: Lead Clinical Trials & Analytics

Cytel; Salem (OR); On-site; USD 140,000 - 210,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for a major client across Phase I–IV trials. You will drive study design, analysis plans, and integrated analyses, collaborating with cross-functional teams and external vendors.

The role emphasizes advanced statistics, CDISC/ISS submissions, and leadership in a fast-paced pharmaceutical setting, with strong communication and autonomy in a client-embedded environment.

Qualifications

• Master's degree in Statistics, Biostatistics, or related field; PhD strongly preferred.
• 8-10 years of biostatistics experience in clinical trials; CRO experience preferred.
• 3-5 years of Study Lead experience with cross-functional teams.
• Extensive experience in study design, sample size, SAP development, ISS/ISE.
• Strong knowledge of ICH guidelines and regulatory expectations.

Responsibilities

• Participate in development of study protocols, study design discussions, and sample size calculations.
• Perform exploratory data analyses to evaluate study trends and support decision-making.
• Apply advanced statistical methods, including mixed models, for efficacy and longitudinal analyses.
• Design and execute simulation studies to evaluate designs and methodologies.
• Lead efficacy analyses and interpretation of primary and secondary endpoints.
• Review CRFs and develop SAPs including analysis datasets and TLF specifications.
• Perform statistical analyses and interpret results.
• Lead study activities and provide strategic statistical guidance to cross-functional teams.
• Communicate statistical methodology and implications clearly to non-technical audiences.
• Collaborate across teams and adapt to changing priorities.

Skills

Biostatistics

Statistical analysis

Machine learning

Deep learning

R programming

SAS programming

Communication skills

Team leadership

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

CDISC standards

Job description

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for a major client across Phase I–IV trials. You will drive study design, analysis plans, and integrated analyses, collaborating with cross-functional teams and external vendors.

The role emphasizes advanced statistics, CDISC/ISS submissions, and leadership in a fast-paced pharmaceutical setting, with strong communication and autonomy in a client-embedded environment.