Senior Biostatistician — Lead Clinical Trials & Analytics

Cytel; Helena (MT); Remote; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Biostatistician to lead Phase I–IV clinical studies across our client region. You will provide statistical and development support, influence study design, SAPs and regulatory submissions, and guide cross‑functional teams to actionable insights.

The ideal candidate holds a Master’s in Statistics or Biostatistics (PhD preferred), with 8–10 years in pharma/biotech biostatistics, and 3–5 years as Study Lead.

Qualifications

• Master's in Statistics or Biostatistics; PhD preferred.
• 8–10 years biostatistics in pharma/biotech; CRO exp preferred.
• 3–5 years Study Lead with cross-functional teams.
• Design study, SAP, ISS/ISE, and regulatory submissions.
• Strong knowledge of ICH guidelines.
• CDISC standards for regulatory submissions.
• ADaM specs development and dataset review.
• Excellent communication for technical/non-technical audiences.
• Collaborative, high-quality work under tight timelines.
• Thrive in a dynamic, ambiguous environment.

Responsibilities

• Participate in protocol development and sample size discussions.
• Lead exploratory analyses to support decision-making.
• Apply advanced statistical methods for efficacy and longitudinal analyses.
• Design and execute simulations to evaluate designs.
• Lead efficacy analyses and interpretation of endpoints.
• Review CRFs and develop SAPs and data specifications.
• Perform statistical analyses and interpret results.
• Provide strategic statistical guidance to cross-functional teams.
• Communicate methodology clearly to non-technical audiences.
• Collaborate to meet project goals and timelines.
• Adapt to evolving priorities.

Skills

Statistical analysis

Study leadership

Cross-functional collaboration

Communication skills

R programming

Education

Master's degree in Statistics/Biostatistics

PhD strongly preferred

Tools

SAS

CDISC

ADaM

Job description

Cytel is seeking a Principal Biostatistician to lead Phase I–IV clinical studies across our client region. You will provide statistical and development support, influence study design, SAPs and regulatory submissions, and guide cross‑functional teams to actionable insights.

The ideal candidate holds a Master’s in Statistics or Biostatistics (PhD preferred), with 8–10 years in pharma/biotech biostatistics, and 3–5 years as Study Lead.