Lead Principal Biostatistician - Clinical Trials & Analytics

Cytel; Santa Fe (NM); Vor Ort; USD 150.000 - 230.000; Vollzeit

Zusammenfassung

Cytel is seeking an experienced Principal Biostatistician to lead statistical strategy and analyses for Phase I–IV clinical trials within a sponsor-dedicated setup. You will collaborate with clients and Cytel teams to influence development plans, SAPs, and regulatory submissions.

You will apply advanced methods, including mixed models and simulations, and mentor junior staff while communicating complex concepts clearly to stakeholders.

Qualifikationen

• Master's degree in Statistics, Biostatistics, or a related discipline. PhD strongly preferred.
• 8-10 years of biostatistics experience in clinical trials (pharma/biotech). CRO experience preferred.
• 3-5 years of Study Lead experience with cross-functional teams.
• Extensive study design, sample size, protocol, SAP, ISS/ISE experience.

Aufgaben

• Lead statistical analyses and interpretation across Phase I–IV trials.
• Develop SAPs, analysis datasets, and TLF specifications.
• Collaborate with cross-functional teams and external vendors as needed.
• Present statistics and implications to technical and non-technical audiences.
• Ensure regulatory submission readiness with ISS/ISE experience.

Kenntnisse

Communication skills

Collaboration

Adaptability

Ausbildung

Master's in Statistics/Biostatistics

PhD preferred

Tools

R

SAS

ADaM

ISS/ISE

Jobbeschreibung

Cytel is seeking an experienced Principal Biostatistician to lead statistical strategy and analyses for Phase I–IV clinical trials within a sponsor-dedicated setup. You will collaborate with clients and Cytel teams to influence development plans, SAPs, and regulatory submissions.

You will apply advanced methods, including mixed models and simulations, and mentor junior staff while communicating complex concepts clearly to stakeholders.