Senior Biostatistician & Study Lead – Clinical Trials

Cytel; Topeka (KS); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel is seeking a Principal Biostatistician to lead one or more clinical studies from design through analysis and regulatory submission. The role emphasizes advanced statistical methods, study design, SAS/R analytics and collaboration with cross-functional teams across Phase I–IV trials.

You will drive statistical strategy, ensure CDISC standards, and provide leadership to ensure project timelines and high-quality deliverables for regulatory submissions.

Qualifications

• Master's degree in Statistics or Biostatistics; PhD preferred.
• 8–10 years of biostatistics experience supporting clinical trials; CRO experience preferred.
• 3–5 years of Study Lead experience with cross-functional development teams.
• Strong knowledge of ICH guidelines and regulatory expectations.
• Experience with CDISC standards and ISS/ISE submissions.

Responsibilities

• Provide statistical support for study protocols, design discussions and sample size calculations.
• Lead and contribute to efficacy analyses and interpretation of endpoints.
• Review CRFs, draft SAPs and ISS/ISE submissions with data analysis plans.
• Develop integrated analytic approaches using advanced methods and simulations.
• Communicate statistical methodologies clearly to non-technical audiences.
• Collaborate with cross-functional teams to drive timelines and quality.
• Lead studies when needed and provide strategic statistical guidance.
• Ensure regulatory and CDISC standards compliance across analyses.

Skills

R programming

SAS programming

Statistical modeling

Study design

Clinical trials

Regulatory submissions

CDISC ADaM standards

Communication (non-technical)

Cross-functional leadership

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

ADaM software

CDISC standards

Job description

Cytel is seeking a Principal Biostatistician to lead one or more clinical studies from design through analysis and regulatory submission. The role emphasizes advanced statistical methods, study design, SAS/R analytics and collaboration with cross-functional teams across Phase I–IV trials.

You will drive statistical strategy, ensure CDISC standards, and provide leadership to ensure project timelines and high-quality deliverables for regulatory submissions.