Principal Biostatistician: Lead Global Clinical Trials

Cytel

Hartford (CT)

Sur place

USD 150 000 - 210 000

Plein temps

Il y a 8 jours

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Résumé du poste

Cytel is seeking a Principal Biostatistician to lead statistical development for Phase I–IV client trials, guiding study design, analyses, and regulatory submissions. You will collaborate with clients and Cytel teams to advance development plans and ensure high-quality statistical deliverables.

You will apply advanced modeling, design simulations, and ISS/ISE-oriented analyses while communicating complex concepts to non-technical audiences and maintaining timelines in a dynamic, client-focused

Qualifications

Experience leading Phase I–IV trials in the pharmaceutical/biotech industry.
Proven ability to design studies, perform SAS/R analyses, and contribute to regulatory submissions.
Experience with ISS/ISE and ADaM specifications.

Responsabilités

Lead and influence statistical development for client trials.
Develop SAPs, analysis datasets, and TLF specifications.
Design and execute simulation studies to evaluate study designs and methods.
Lead efficacy analyses and interpretation of endpoints.
Present statistical methods and assumptions to cross-functional teams in clear language.
Collaborate with cross-functional teams to meet project timelines.
Review CRFs and data review guidelines; ensure regulatory standards compliance.