Principal Biostatistician - Lead Clinical Analytics

Cytel; Trenton (NJ); Presencial; USD 170.000 - 230.000; Jornada completa

Descripción de la vacante

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV clinical studies within a sponsor-dedicated setup. You will shape integrated analytical plans, apply advanced methods, and oversee analyses across trials while collaborating with clients and Cytel teams.

Ideal candidates have 8–10 years in biostatistics within pharma/biotech, with SAS and R proficiency, CDISC standards, and strong communication for regulatory submissions and cross-functional

Formación

• Master's degree in Statistics, Biostatistics, or related field; PhD strongly preferred.
• 8-10 years biostatistics experience in pharma/biotech; CRO experience is a plus.
• 3-5 years Study Lead experience with cross-functional teams.
• Extensive experience in study design, sample size, protocol development, SAPs, ISS/ISE.
• Strong knowledge of mixed models, longitudinal analyses, and simulations.
• Experience with regulatory submissions and ISS/ISE.
• Excellent communication to both technical and non-technical audiences.

Responsabilidades

• Participate in development of study protocols and design discussions.
• Lead efficacy analyses and interpretation of endpoints.
• Review CRFs and develop SAPs and analysis datasets.
• Design and run simulation studies to evaluate designs.
• Provide strategic statistical guidance to cross-functional teams.
• Present statistical methods and implications clearly to stakeholders.
• Collaborate with statisticians and programmers to ensure quality outputs.

Conocimientos

R

SAS

CDISC

ISS/ISE

Study Lead

Statistical modelling

Data visualization

Regulatory submissions

Communicating results

Educación

Master's in Statistics/Biostatistics

PhD preferred

Herramientas

R

SAS

Descripción del empleo

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV clinical studies within a sponsor-dedicated setup. You will shape integrated analytical plans, apply advanced methods, and oversee analyses across trials while collaborating with clients and Cytel teams.

Ideal candidates have 8–10 years in biostatistics within pharma/biotech, with SAS and R proficiency, CDISC standards, and strong communication for regulatory submissions and cross-functional