Senior Biostatistician, Clinical Trials & Advanced Analytics

Cytel; San Juan (PR); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV trials within a sponsor-dedicated, embedded client setting. You will shape analytical plans, oversee datasets, and guide cross-functional teams to deliver robust regulatory submissions.

Ideal candidates hold a Master's in Statistics/Biostatistics (PhD preferred) with 8–10 years of biostatistics and 3–5 years in study lead roles, and strong R/SAS proficiency.

Qualifications

• Master's degree in Statistics/Biostatistics or related discipline; PhD strongly preferred.
• 8–10 years biostatistics experience supporting clinical trials in pharma/biotech.
• 3–5 years Study Lead experience with cross-functional teams.
• Extensive study design, sample size, protocol SAP development, efficacy analyses, ISS/ISE.
• Strong knowledge of advanced statistics including mixed models and simulations.
• Experience with exploratory analyses to support development decisions.
• Proficiency in R for analyses, simulations, and visualization.
• Solid SAS programming and QC of outputs with cross-functional collaboration.
• Knowledge of ICH guidelines and regulatory expectations.
• CDISC standards for regulatory submissions.
• Experience generating ADaM specs and auditing analysis datasets.
• Regulatory submission experience (ISS/ISE) desired.
• Excellent communication to explain statistics to technical/non-technical audiences.
• Collaborative mindset and ability to meet tight timelines.
• Ability to thrive in dynamic environments and adapt to change.

Responsibilities

• Provide statistical support across Phase I–IV trials and client studies.
• Lead protocol development discussions, design, and sample size calculations.
• Develop SAPs and analysis datasets; oversee endpoints.
• Lead efficacy analyses and interpretation of primary and secondary endpoints.
• Design and run simulation studies to evaluate designs and methods.
• Present statistical methodology and implications to non-technical audiences.
• Collaborate with cross-functional teams and external vendors.
• Ensure regulatory submissions comply with CDISC/ISS/ISE standards.

Skills

Communication skills

Collaboration

Adaptability

Leadership

Analytical thinking

Education

Master's degree in Statistics/Biostatistics or related discipline

PhD preferred

Tools

R

SAS

Job description

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV trials within a sponsor-dedicated, embedded client setting. You will shape analytical plans, oversee datasets, and guide cross-functional teams to deliver robust regulatory submissions.

Ideal candidates hold a Master's in Statistics/Biostatistics (PhD preferred) with 8–10 years of biostatistics and 3–5 years in study lead roles, and strong R/SAS proficiency.