Principal Statistician, Biostatistics

🔥 3 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• 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

• 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

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