Senior Biostatistician Lead — Clinical Trials & Analytics

Cytel; Sacramento (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies across the region, applying advanced statistical methods and modeling to push development forward. You will collaborate with clients and cross-functional teams, oversee SAPs and ISS/ISE planning, and mentor Study Leads while delivering robust analyses and clear explanations of complex results.

You will demonstrate leadership, strong communication skills, and the ability to thrive in a

Qualifications

• Master's degree in Statistics or Biostatistics.
• 8–10 years of biostatistics experience in clinical trials.
• 3–5 years of Study Lead experience with cross-functional development teams.
• Strong knowledge of advanced statistical methods including mixed models and longitudinal analyses.
• Experience generating ADaM specifications and regulatory submission experience is preferred.

Responsibilities

• Participating in study protocol development, design discussions and sample size determinations.
• Leading exploratory analyses to support scientific decision-making and trial insights.
• Applying advanced statistical methods to efficacy analyses and longitudinal studies.
• Designing and executing simulation studies to evaluate study designs and methods.
• Providing strategic statistical guidance to cross-functional teams and communicating results clearly.

Skills

R

SAS

CDISC standards

ADaM specifications

Regulatory submissions

ICH guidelines

Education

Master's degree in Statistics or Biostatistics

PhD preferred

Tools

R software

SAS software

CDISC (ADaM/ISS/ISE)

Job description

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies across the region, applying advanced statistical methods and modeling to push development forward. You will collaborate with clients and cross-functional teams, oversee SAPs and ISS/ISE planning, and mentor Study Leads while delivering robust analyses and clear explanations of complex results.

You will demonstrate leadership, strong communication skills, and the ability to thrive in a