Principal Statistician, Biostatistics

🔥 12 hours 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

• Support the design and reporting of Phase I to IV clinical studies • Support regulatory filings under the supervision of a more senior statistician • Lead statistical aspects of study design, analysis, validation, and documentation • Provide statistical expertise for clinical trials, including early-stage trials • Develop and execute statistical strategy, design, and analyses • Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations • Oversee statistics and programming work performed by external vendors • Participate in data science and cross-functional meetings to optimize study designs, endpoints, and analysis strategies • Support study protocols and review and validate study-specific data capture systems • Develop statistical programs for clinical trial simulations, analyses, data displays, and validation • 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 CDISC SDTM and ADaM standards • Stay current with developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional development

🎯 Requirements

• Knowledge of clinical trial design and analysis, including complex statistical methods and models • Knowledge of statistical principles and methodology, including 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 other statistical applications and programming languages is a plus • Knowledge of applicable regulatory requirements and guidelines, including ICH Guidelines • MSc in statistics, mathematics, or a related discipline with a statistical focus and more than 2 years of pharmaceutical or biotechnology industry experience, or PhD in statistics, mathematics, or a related discipline with a statistical focus and less than 2 years of pharmaceutical or biotechnology industry experience • 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 • Ability to work without close supervision with effective time management

🏖️ Benefits

• Medical, dental and vision insurance • Retirement savings plan • Flexible paid vacation