Senior Principal Statistician, Biostatistics

Overview

As Senior Principal Statistician, you lead statistical strategy and analysis for Phase I–IV studies and regulatory submissions. You’ll design and validate analyses, write SAPs, and guide CRO collaborators, ensuring scientifically sound decisions. You’ll partner across clinical development, pharmacology, regulatory, and medical writing to advance Jazz’s oncology and neuroscience programs. This role blends hands-on statistics with leadership of external vendors and cross-functional teams. You’ll shape study designs and analysis plans in a fast-paced, science-driven environment.

Pay / Benefits

• medical, dental and vision insurance
• retirement savings plan
• flexible paid vacation

Responsibilities

• Lead statistical design and analysis across individual and related studies, and integrated summaries
• Collaborate with cross-functional teams to optimize study designs, endpoints, and analysis plans
• Develop and implement study protocols, SAPs, and statistical programs; validate analyses
• Coordinate with CROs to ensure timely, high-quality deliverables and review CRO outputs
• Prepare data displays, simulate trial design operating characteristics, and assess data validity
• Interact with regulatory agencies for submissions and responses
• Mentor and align biostatistics standards with therapeutic area leads and colleagues
• Oversee external vendors’ statistical work and maintain quality control of deliverables
• Serve as statistical SME with medical writers for clinical reports and integrated summaries
• Respond to regulatory statistical questions and support regulatory interactions

Key requirements

• Clinical trial design and analysis expertise across II–IV phases, including advanced statistical methods
• Proficiency in SAS and R; familiarity with additional programming languages a plus
• Knowledge of ICH guidelines, regulatory requirements, and CDISC standards
• Ability to work in a fast-paced, team-oriented environment with strong communication
• Excellent written and verbal communication and leadership abilities
• Strong attention to detail and time management; independent work capability

• strong communication
• leadership
• collaboration
• SAS
• R
• CDISC standards

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