Senior Principal Statistician, Biostatistics

🔥 4 minutes ago

🌐 United Kingdom, Ireland – Remote

🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🟠 Senior

🇬🇧 UK Skilled Worker Visa Sponsor

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👻 Ghost score 10%

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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 statistics for individual studies, related studies, integrated summaries, and regulatory filings • Design and report Phase I to IV clinical studies • Provide statistical expertise to clinical development projects • Develop and execute statistical strategy, study designs, and clinical-trial analyses • Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations • Manage work performed by external statistics and programming vendors • Participate in department and cross-functional meetings to optimize study designs, endpoints, and analysis strategies • Support development and implementation of study protocols • Review and help validate data capture systems • Develop statistical programs for clinical-trial simulations, analyses, data displays, and validation • Write and review statistical analysis plans • Perform and oversee data analysis and validation, and interpret analyses • Prepare for and attend regulatory-agency meetings • Develop, implement, and maintain department standards and practices • Review CRO timelines and analysis plans for timeliness and quality • Review and validate CRO deliverables • Act as statistical subject matter expert for clinical reports, integrated summaries, and other documents • Respond to statistical questions from regulatory agencies

🎯 Requirements

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 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 and methodology, statistical inference, hypothesis testing, estimates, parametric and non-parametric models and techniques, sample size calculations, design of experiments, and Phase II-IV clinical trial data analysis • Experience using SAS and R • Knowledge of applicable regulatory requirements and guidelines, including ICH Guidelines, drug development regulatory requirements, statistical contributions to marketing applications, and CDISC standards • Knowledge of drug development regulations pertinent to statistical analysis • Proficient SAS and R programming skills • Solid understanding of CDISC models and standards • Excellent writing and communication skills • Demonstrated leadership abilities and excellent interpersonal skills • Ability to work in a fast-paced, flexible, team-oriented environment • Strong attention to detail • Ability to work without close supervision • Well-developed time management skills • Knowledge of oncology or hematology therapeutic area is preferred • Bayesian and adaptive design experience is preferred • Experience in Phase I/II Oncology studies and Phase I healthy volunteer/clinical pharmacology studies for Neuroscience is preferred

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Retirement savings plan • Flexible paid vacation