Senior Principal Biostatistician - Clinical Trials Leader

Cytel; Lincoln (NE); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV trials within a sponsor-dedicated role. You will guide study design, analyses, and regulatory submissions, leveraging R and SAS and advanced methods to generate actionable insights for a major pharmaceutical client.

You will contribute to development plans, SAPs, ISS/ISE, and cross-functional teams, using strong communication to explain statistical implications to non-technical audiences.

Formación

• Master's degree in Statistics or Biostatistics; PhD strongly preferred.
• 8-10 years of biostatistics experience in pharma/biotech; CRO experience preferred.
• 3-5 years of Study Lead experience with cross-functional teams.
• Expertise in study design, sample size, SAP, ISS/ISE and regulatory submissions.

Responsabilidades

• Develop study protocols, design discussions and sample size calculations.
• Conduct exploratory analyses to support decision making and trends.
• Apply advanced methods including mixed models and longitudinal analyses.
• Design and execute simulation studies to evaluate designs and methods.
• Lead efficacy analyses and interpretation of endpoints.
• Develop SAPs and ISS/ISE documentation; review analysis datasets.
• Communicate statistical results to non-technical stakeholders.
• Collaborate across teams to meet project goals and timelines.

Conocimientos

Leadership

Communication

Regulatory knowledge

CDISC standards

Cross-functional collaboration

Data analysis

Study design

Sample size determination

Educación

Master's degree in Statistics/Biostatistics

PhD strongly preferred

Herramientas

R

SAS

Descripción del empleo

Cytel is seeking an experienced Principal Biostatistician to lead statistical support for Phase I–IV trials within a sponsor-dedicated role. You will guide study design, analyses, and regulatory submissions, leveraging R and SAS and advanced methods to generate actionable insights for a major pharmaceutical client.

You will contribute to development plans, SAPs, ISS/ISE, and cross-functional teams, using strong communication to explain statistical implications to non-technical audiences.