Embedded Principal Biostatistician, Clinical Trials

Cytel; Richmond (VA); On-site; USD 140,000 - 180,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies across the region, embedded with a client and backed by Cytel. You'll shape study design, SAPs, ISS/ISEs, and integrated analyses, applying advanced modeling and simulation to drive decision making.

Expect to guide cross-functional teams, present statistical concepts clearly, and adapt to evolving priorities while ensuring timely, high-quality results.

Qualifications

• Master's degree in Statistics or Biostatistics; PhD preferred.
• 8–10 years of biostatistics experience in clinical trials.
• 3–5 years of Study Lead experience with cross-functional teams.
• Extensive experience in study design, sample size, SAP development, ISS/ISE.
• Strong proficiency in R and SAS; knowledge of regulatory submissions.
• Experience with CDISC standards and ADaM specifications.

Responsibilities

• Participate in study protocols, design discussions and sample size calculations.
• Lead exploratory analyses to support data-driven decisions across development.
• Apply advanced statistical methods for efficacy and longitudinal analyses.
• Design and execute simulation studies to evaluate designs.
• Lead efficacy analyses and interpretation of primary/secondary endpoints.
• Review CRFs, develop SAPs and ISS/ISE documentation.
• Perform statistical analyses and communicate results to teams.
• Provide strategic statistical guidance and cross-functional leadership.
• Present methods and implications clearly to non-technical audiences.
• Collaborate proactively to meet project goals and timelines.
• Adapt to shifting priorities in a dynamic environment.

Skills

R programming

SAS programming

Statistical modeling

Cross-functional collaboration

Regulatory submissions

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

ADaM specifications

CDISC standards

ISS/ISE familiarity

Job description

Cytel is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies across the region, embedded with a client and backed by Cytel. You'll shape study design, SAPs, ISS/ISEs, and integrated analyses, applying advanced modeling and simulation to drive decision making.

Expect to guide cross-functional teams, present statistical concepts clearly, and adapt to evolving priorities while ensuring timely, high-quality results.