Senior Principal Biostatistician — Clinical Trials Lead

Cytel; Concord (NH); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel Inc. is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies within the region.

You will provide statistical expertise for study design, analyses, and regulatory submissions, while guiding cross-functional teams and collaborating with clients to drive innovation. You will apply advanced methodologies, mixed models, and simulations to develop integrated analytical plans, oversee SAPs, and ensure timely, high-quality deliverables.

Qualifications

• Master's degree in Statistics, Biostatistics, or related discipline required.
• PhD strongly preferred.
• Extensive biostatistics experience in clinical trials.
• Strong proficiency in R for analyses and simulations.
• Solid SAS programming skills and QC of outputs.
• Knowledge of ICH guidelines and CDISC standards.

Responsibilities

• Lead statistical analyses and interpretation for trials across phases.
• Develop SAPs, analysis datasets, and TLF specifications.
• Design and implement study designs, sample size calculations, and simulations.
• Contribute to efficacy analyses and regulatory submissions (ISS/ISE).
• Collaborate with cross-functional teams and communicate complex methods clearly.

Skills

Cross-functional leadership

Analytical thinking

Regulatory understanding

Project management

Education

Master's degree in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

CDISC

ADaM

ISS/ISE

Job description

Cytel Inc. is seeking an experienced Principal Biostatistician to lead one or more Phase I–IV clinical studies within the region.

You will provide statistical expertise for study design, analyses, and regulatory submissions, while guiding cross-functional teams and collaborating with clients to drive innovation. You will apply advanced methodologies, mixed models, and simulations to develop integrated analytical plans, oversee SAPs, and ensure timely, high-quality deliverables.