Principal Biostatistician — Lead Embedded Clinical Trials

Cytel

Salt Lake City (UT)

In loco

USD 150.000 - 210.000

Tempo pieno

6 giorni fa

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Descrizione del lavoro

Cytel is seeking an experienced Principal Biostatistician to lead Phase I–IV trials for a pharmaceutical client. You will develop integrated analytical approaches, apply advanced statistics, and guide cross-functional teams.

You will influence study design, SaPs, ISS/ISE submissions, and regulatory interactions from a sponsor-dedicated role within Cytel. The role requires strong R/SAS skills, CDISC/ADaM experience, and a strategic mindset to drive timely, high-quality clinical analysis and

Competenze

Master's degree in Statistics or Biostatistics; PhD strongly preferred.
8–10 years of biostatistics experience in clinical trials in pharma/biotech.
3–5 years of Study Lead experience with cross-functional teams.

Mansioni

Participate in development of study protocols and sample size calculations.
Lead exploratory analyses to support scientific decision-making.
Apply advanced statistical methods for efficacy and longitudinal analyses.
Design and execute simulation studies to evaluate designs and methods.
Lead efficacy analyses and interpretation of endpoints.
Review CRFs and develop SAPs, including analysis datasets and TLF specs.
Provide strategic statistical guidance to cross-functional teams.
Communicate statistical methods and implications clearly to non-technical audiences.