Senior Biostatistician — Clinical Trials & Analytics Lead

Cytel; Frankfort (KY); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytel Inc. seeks an experienced Principal Biostatistician to lead statistical support for Phase I–IV trials across the region. You will influence study design, SAPs, and regulatory submissions while guiding cross-functional teams and communicating complex methods clearly.

The role requires 8–10 years in biostatistics, strong modeling skills, and proficiency with R and SAS. You will collaborate with sponsor teams, perform simulations, and drive high-quality analyses under tight timelines.

Qualifications

• Master's degree or higher in Statistics, Biostatistics, or related field.
• 8–10 years in biostatistics supporting clinical trials.
• Experience leading cross-functional development teams.
• Strong knowledge of study design, SAP development, and ISS/ISE.
• Excellent communication of statistical concepts to non-technical audiences.

Responsibilities

• Participate in study design discussions and sample size calculations.
• Lead efficacy analyses and interpretation of primary/secondary endpoints.
• Review CRFs and develop SAPs with analysis datasets.
• Conduct exploratory analyses to support scientific decisions.
• Provide strategic statistical guidance to cross-functional teams.
• Present statistical methodologies and implications clearly to clients.

Skills

Study Lead experience

Communication skills

Cross-functional collaboration

Regulatory submissions

Leadership

Education

Master's degree in Statistics or Biostatistics

PhD preferred

Tools

R

SAS

CDISC

ADaM

Job description

Cytel Inc. seeks an experienced Principal Biostatistician to lead statistical support for Phase I–IV trials across the region. You will influence study design, SAPs, and regulatory submissions while guiding cross-functional teams and communicating complex methods clearly.

The role requires 8–10 years in biostatistics, strong modeling skills, and proficiency with R and SAS. You will collaborate with sponsor teams, perform simulations, and drive high-quality analyses under tight timelines.