Principal Biostatistician - Clinical Trials Leader

Cytel; Augusta (ME); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytel is seeking a Principal Biostatistician to lead Phase I-IV clinical studies across the region. You will apply advanced statistical methods, design studies, develop SAPs, and guide cross-functional teams on regulatory submissions.

You will collaborate with clients and vendors, provide strategic statistical direction, and mentor junior staff while ensuring high-quality analyses and timely delivery in a dynamic pharmaceutical environment.

Qualifications

• Master's degree in Statistics, Biostatistics, or related field; PhD preferred.
• 8-10 years of biostatistics experience in pharma/biotech; CRO experience preferred.
• 3-5 years of Study Lead experience with cross-functional teams.
• Strong knowledge of ICH guidelines and regulatory expectations.
• Solid CDISC ADaM and ISS/ISE experience for regulatory submissions.
• Excellent communication skills to explain statistical methods to diverse audiences.

Responsibilities

• Lead study design discussions, sample size calculations, and SAP development.
• Conduct exploratory analyses and support decision-making across trial phases.
• Apply mixed models and longitudinal analyses for efficacy evaluations.
• Design and run simulation studies to evaluate designs and methods.
• Lead efficacy analyses and interpretation of endpoints; support regulatory submissions.
• Prepare ISS/ISE and integrated summaries; ensure rigorous data review.
• Present statistical methodology clearly to cross-functional teams and clients.

Skills

Strong communication skills

Collaborative mindset

Adaptability

Leadership

Education

Master's degree in Statistics/Biostatistics

PhD strongly preferred

Tools

SAS

R

CDISC standards

ISS/ISE experience

Job description

Cytel is seeking a Principal Biostatistician to lead Phase I-IV clinical studies across the region. You will apply advanced statistical methods, design studies, develop SAPs, and guide cross-functional teams on regulatory submissions.

You will collaborate with clients and vendors, provide strategic statistical direction, and mentor junior staff while ensuring high-quality analyses and timely delivery in a dynamic pharmaceutical environment.