Lead Principal Biostatistician – Clinical Trials & Analytics

Cytel; Lansing (MI); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead statistical support across Phase I–IV clinical studies within the client context. You will influence study plans, datasets, and regulatory submissions, partnering closely with cross-functional teams.

Ideal candidates have 8–10 years of biostatistics experience, strong R/SAS skills, and a PhD preferred. Expect ownership of analyses, protocols, SAPs, and ISS/ISE in a dynamic Cytel environment.

Qualifications

• Master's degree required in statistics or biostatistics.
• 8–10 years of biostatistics experience in pharma/biotech.
• 3–5 years of Study Lead experience with cross-functional teams.
• Strong knowledge of SAS and R for analyses.
• Understanding regulatory standards (ICH, CDISC) and regulatory submissions.

Responsibilities

• Participate in study protocol development, including design discussions and sample size calculations.
• Perform exploratory data analyses to aid decision-making and trend evaluation.
• Apply advanced methods (mixed models, longitudinal analyses) for efficacy analyses.
• Design and run simulation studies to compare designs and methods.
• Lead efficacy analyses and interpretation of primary/secondary endpoints.
• Review SAPs and data review guidelines; ensure analysis datasets and ISS/ISE readiness.

Skills

R

SAS

CDISC

Study Lead

Cross-functional collaboration

Education

Master's degree in Statistics or Biostatistics

PhD preferred

Tools

ADaM

ISS/ISE

Clinical Data Standards

Job description

Cytel is seeking an experienced Principal Biostatistician to lead statistical support across Phase I–IV clinical studies within the client context. You will influence study plans, datasets, and regulatory submissions, partnering closely with cross-functional teams.

Ideal candidates have 8–10 years of biostatistics experience, strong R/SAS skills, and a PhD preferred. Expect ownership of analyses, protocols, SAPs, and ISS/ISE in a dynamic Cytel environment.