Lead Biostatistician – Clinical Trials & Analytics

Cytel; Trenton (NJ); On-site; USD 160,000 - 260,000; Full time

Job summary

Cytel seeks an experienced Principal Biostatistician to lead regional Phase I–IV clinical studies, providing statistical strategy, design input, and integrated analyses. You will mentor teams, collaborate with clients, and drive advanced methods including mixed models and simulations to enable robust decision-making.

The role emphasizes strong communication, CDISC/ISS-ISE experience, and leadership of cross-functional pharmacometrics and data sciences teams in a client-embedded environment.

Qualifications

• Master's degree in Statistics, Biostatistics, or related discipline; PhD preferred.
• 8–10 years of biostatistics experience in clinical trials (pharma/biotech).
• 3–5 years of Study Lead experience with cross-functional teams.
• Experience in study design, SAP development, ISS/ISE submissions.
• Strong knowledge of regression/mixed models, longitudinal analyses and simulations.
• Proficient in R for analyses, simulations, and visualization; solid SAS skills.
• Knowledge of ICH guidelines and CDISC for regulatory submissions.

Responsibilities

• Lead clinical studies from Phase I to IV across the region.
• Develop study protocols, discuss design and sample size with teams.
• Perform exploratory analyses to guide decision-making and insights.
• Apply advanced statistical methods for efficacy and longitudinal analyses.
• Design and run simulations to evaluate study designs and methods.
• Lead and contribute to efficacy analyses and interpretation of endpoints.
• Prepare SAPs, analysis datasets, ISS/ISE, and regulatory deliverables.
• Communicate statistical methodology clearly to technical and non-technical audiences.
• Collaborate with cross-functional teams to meet timelines and goals.

Skills

R

SAS

CDISC

ADaM

ISS/ISE

Regulatory submissions

Cross-functional leadership

Statistical analysis

Education

Master's degree in Statistics or Biostatistics

PhD preferred

8-10 years biostatistics experience

Tools

R (advanced)

SAS programming

CDISC standards

Job description

Cytel seeks an experienced Principal Biostatistician to lead regional Phase I–IV clinical studies, providing statistical strategy, design input, and integrated analyses. You will mentor teams, collaborate with clients, and drive advanced methods including mixed models and simulations to enable robust decision-making.

The role emphasizes strong communication, CDISC/ISS-ISE experience, and leadership of cross-functional pharmacometrics and data sciences teams in a client-embedded environment.