Principal Statistician, Biostatistics

Jazz Pharmaceuticals

. Lead statistical support for the design and reporting of Phase I to IV clinical studies .

Posted 9/22/2026full-timeRemote • United KingdomLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and clinical trial design, with proficiency in SAS and R programming. Capable of developing statistical strategies and collaborating effectively with cross-functional teams to ensure compliance with regulatory standards.

Highest-signal resume keywords

Statistical Analysis PlansClinical Trial DesignSAS ProgrammingR ProgrammingRegulatory Requirements Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical InferenceHypothesis TestingSample Size CalculationsBayesian Design KnowledgeExperimental Design

Soft Skills

Excellent Writing SkillsInterpersonal SkillsLeadership SkillsAttention to DetailTime Management

Tools & Technologies

SASRCDISC SDTMCDISC ADaM

Industry Keywords

Phase I-IV Clinical StudiesRegulatory FilingsICH GuidelinesPharmaceutical IndustryBiotechnology Industry

About the role

Key responsibilities & impact

Lead statistical support for the design and reporting of Phase I to IV clinical studies
Support regulatory filings under the supervision of a more senior statistician
Manage statistical aspects of study design, analysis, validation, and documentation
Develop and execute statistical strategy, design, and analyses for clinical trials
Participate in data science and cross-functional meetings to optimize study designs, endpoints, and analysis strategies
Collaborate with study teams to meet study and recurring report timelines
Support development and implementation of study protocols
Review and validate study-specific data capture systems
Develop statistical programs to simulate trial design operating characteristics, perform analyses, prepare data displays, and verify data accuracy and validity
Write statistical analysis plans, perform data analysis and validation, and interpret analyses
Support the project lead statistician
Prepare for and attend regulatory agency meetings and respond to statistical questions
Work closely with statistical programming colleagues
Monitor CRO guidelines and standards and review and validate CRO deliverables
Collaborate with medical writers on clinical reports, integrated summaries, and other documents
Learn and apply drug development regulatory requirements, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards
Stay current with developments in statistics, drug development, and regulatory guidance

Requirements

What you’ll need

MSc in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in pharmaceutical or biotechnology industry
OR PhD in statistics, mathematics, or a related discipline with a statistical focus and < 2 years of experience in the pharmaceutical or biotechnology industry
Knowledge of clinical trial design and analysis, including complex statistical methods and models
Knowledge of statistical principles, methodology, statistical inference, hypothesis testing, estimates, parametric and non-parametric models, sample size calculations, experimental design, and Phase II-IV clinical trial data analysis
Experience using SAS and R
Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines
Knowledge of drug development regulations pertinent to statistical analysis
Proficient SAS and R programming skills
Understanding of CDISC models and standards
Excellent writing, communication, interpersonal, and leadership skills
Ability to work in a fast-paced, flexible, team-oriented environment
Strong attention to detail and effective time management
Ability to work without close supervision
Bayesian and adaptive design knowledge is preferred

Benefits

Comp & perks

Medical, dental and vision insurance
Retirement savings plan
Flexible paid vacation
Professional development activities, including conference attendance