Principal Biostatistician: Lead Clinical Analytics & Trials

Cytel

Pierre (SD)

On-site

USD 180,000 - 230,000

Full time

5 days ago
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Benefits offered by this job

Equal employment opportunity

Job summary

Cytel Inc. is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the region, driving statistical strategy, study design, and regulatory submissions with clients.

You will apply advanced methods, oversee SAPs, ISS/ISE, simulate designs, and mentor Study Leads while collaborating with cross-functional teams and communicating complex concepts clearly.

Qualifications

  • Master's degree in Statistics, Biostatistics, or a related discipline. PhD strongly preferred.
  • 8-10 years of biostatistics experience supporting clinical trials in pharma/biotech. CRO experience preferred.
  • 3-5 years of Study Lead experience with cross-functional teams.
  • Strong knowledge of ICH guidelines and CDISC standards for regulatory submissions.

Responsibilities

  • Lead statistical strategy for Phase I–IV trials and oversee SAP development.
  • Design studies, perform sample size calculations, and contribute to protocols and ISS/ISE.
  • Lead efficacy analyses and interpretation of primary and secondary endpoints.
  • Provide strategic statistical guidance to cross-functional teams and mentor junior staff.

Skills

R
Cross-functional leadership
Communication
Statistical modeling

Education

Master's in Statistics/Biostatistics
PhD preferred

Tools

SAS

Job description

Cytel Inc. is seeking an experienced Principal Biostatistician to lead Phase I–IV clinical studies across the region, driving statistical strategy, study design, and regulatory submissions with clients.

You will apply advanced methods, oversee SAPs, ISS/ISE, simulate designs, and mentor Study Leads while collaborating with cross-functional teams and communicating complex concepts clearly.

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