Senior Biostatistician - Clinical Development Lead

Cytel; Helena (MT); Presencial; USD 130.000 - 180.000; Jornada completa

Descripción de la vacante

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV clinical studies across the region. You will collaborate with clients and Cytel teams to advance development, apply advanced modeling, and drive insights that inform decision-making.

The role emphasizes study design, SAS/R analyses, and regulatory submissions, with responsibility for creating SAPs and integrated summaries while mentoring teams in a fast-paced environment.

Formación

• Master's degree required; PhD strongly preferred.
• 8-10 years biostatistics experience in pharma/biotech.
• 3-5 years Study Lead exposure with cross-functional teams.
• Experience with study design, SAPs, ISS/ISE and integrated summaries.

Responsabilidades

• Participate in study protocol development, design discussions and sample size calculations.
• Lead exploratory data analyses to support scientific decision-making.
• Apply advanced statistical methods for efficacy and longitudinal analyses.
• Design and execute simulation studies to evaluate study designs.
• Lead efficacy analyses and interpretation of endpoints.
• Develop SAPs, analysis datasets, and ISS/ISE preparation.
• Provide strategic statistical guidance to cross-functional teams.
• Present statistical methods and implications clearly to non-technical audiences.

Conocimientos

Strong communication

Cross-functional leadership

Statistical modeling

Ability to explain methodology to non-

Educación

Master's degree in Statistics/Biostatistics or related

PhD strongly preferred

Herramientas

R

SAS

CDISC standards

ISS/ISE regulatory submission experience

Descripción del empleo

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV clinical studies across the region. You will collaborate with clients and Cytel teams to advance development, apply advanced modeling, and drive insights that inform decision-making.

The role emphasizes study design, SAS/R analyses, and regulatory submissions, with responsibility for creating SAPs and integrated summaries while mentoring teams in a fast-paced environment.