Senior Biostatistician, Clinical Trials Lead

Cytel; Phoenix (AZ); On-site; USD 180,000 - 280,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV clinical studies embedded with a pharmaceutical client. You will guide study design, analyses and regulatory submissions, mentoring teams and interacting with clients to drive robust conclusions.

The role emphasizes advanced modeling, CDISC standards, and clear communication of complex statistics to non-technical audiences. Based in Phoenix area, on-site with client collaboration.

Qualifications

• 8–10 years of biostatistics experience supporting clinical trials in pharma/biotech.
• Experience leading study design, protocol development, SAPs and ISS/ISE submissions.
• Strong knowledge of CDISC standards and regulatory expectations.
• Excellent communication skills to translate statistics for non-technical stakeholders.
• Proficiency in SAS and R for analyses, simulations, and data visualization.

Responsibilities

• Participate in development of study protocols, design discussions, and sample size calculations.
• Lead exploratory analyses to evaluate trends and support decision making.
• Apply advanced statistical methods including mixed models and longitudinal analyses.
• Design and execute simulation studies to evaluate design operating characteristics.
• Lead efficacy analyses and interpretation of primary and secondary endpoints.
• Review CRFs, develop SAPs and analysis datasets; support ISS/ISE.
• Provide strategic statistical guidance to cross-functional teams.
• Present statistical methodologies and implications clearly to stakeholders.

Skills

Statistical modeling

Cross-functional leadership

Data analysis

Communication of statistics

Experiment design

Education

Master’s degree in Statistics/Biostatistics or related field

PhD strongly preferred

Tools

SAS

R

ADaM specifications

Job description

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV clinical studies embedded with a pharmaceutical client. You will guide study design, analyses and regulatory submissions, mentoring teams and interacting with clients to drive robust conclusions.

The role emphasizes advanced modeling, CDISC standards, and clear communication of complex statistics to non-technical audiences. Based in Phoenix area, on-site with client collaboration.