Principal Biostatistician — Lead Clinical Trials & Analytics

Cytel; City of Albany (NY); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead statistical support across Phase I–IV clinical trials within a sponsor-dedicated role. You will craft integrated analyses, supervise SAPs, and guide cross-functional teams with robust statistical methods, including mixed models and simulations.

Proficiency in R and SAS, and CDISC standards, is essential. The role emphasizes collaboration with clients and regulators, with responsibilities spanning protocol design, data review, and

Qualifications

• MS in Statistics/biostatistics; PhD preferred.
• 8–10 years in biostatistics for clinical trials.
• 3–5 years Study Lead experience with cross-functional teams.
• Strong knowledge of ICH guidelines and CDISC standards.
• Regulatory submission experience (ISS/ISE) strongly desired.

Responsibilities

• Participate in the development of study protocols and design discussions.
• Conduct exploratory analyses to evaluate trends and support decision-making.
• Apply advanced statistical methods for efficacy and longitudinal analyses.
• Design and execute simulation studies to evaluate designs and characteristics.
• Lead efficacy analyses and interpretation of primary and secondary endpoints.
• Develop SAPs and ISS/ISE considerations with data review.
• Perform statistical analyses and interpret results for stakeholders.
• Collaborate with cross-functional teams to meet timelines and goals.
• Communicate statistical methodology clearly to both technical and non-technical audiences.

Skills

Biostatistics

Clinical trials

R programming

SAS programming

Machine learning

Communication

Cross-functional leadership

Education

Master's degree in Statistics

PhD preferred

Tools

R

SAS

Job description

Cytel is seeking an experienced Principal Biostatistician to lead statistical support across Phase I–IV clinical trials within a sponsor-dedicated role. You will craft integrated analyses, supervise SAPs, and guide cross-functional teams with robust statistical methods, including mixed models and simulations.

Proficiency in R and SAS, and CDISC standards, is essential. The role emphasizes collaboration with clients and regulators, with responsibilities spanning protocol design, data review, and