Senior Principal Biostatistician

Job not on LinkedIn

🔥 1 minute ago

🇮🇪 Ireland – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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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Grifols

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1909

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. They focus on the development, production, and distribution of innovative plasma-derived medicines and have a strong commitment to research and development in the pharmaceutical sector. Grifols aims to provide solutions for patients with rare diseases and chronic conditions, contributing significantly to the field of biotechnology and healthcare.

📋 Description

• Serve as the lead biostatistics partner to Clinical Development teams, providing expert input into clinical trial design, methodology, and study execution • Develop and review statistical sections of clinical trial protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) • Lead the analysis, interpretation, validation, and communication of clinical trial data and study results • Ensure the quality, accuracy, and scientific integrity of all statistical deliverables in line with global regulatory requirements and industry standards • Oversee and manage external biostatistics resources, including Contract Research Organizations (CROs) and consultants, ensuring high-quality and timely delivery of work • Review key data management and statistical programming documentation to ensure compliance with regulatory expectations and data quality standards • Lead blinded data review meetings and provide statistical oversight throughout study conduct • Oversee randomization strategy development and randomization schedule generation • Contribute to the development and continuous improvement of statistical processes, methodologies, standards, and Standard Operating Procedures (SOPs) • Represent Biostatistics in cross-functional teams and support interactions with global regulatory authorities, including FDA and other health agencies • Provide statistical expertise for regulatory submissions, health authority meetings, and responses to regulatory questions

🎯 Requirements

• PhD in Statistics, Biostatistics, or a related quantitative discipline with a minimum of 8 years' experience in clinical development within the pharmaceutical or biotechnology industry; alternatively, an MSc with a minimum of 10 years' relevant industry experience • Extensive experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry • Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements • Experience supporting regulatory submissions and interactions with global health authorities • Ability to communicate complex statistical concepts clearly to both technical and non-technical stakeholders • Proven experience leading biostatistical activities across multiple clinical development programs and managing external partners

🏖️ Benefits

• Highly competitive salary • Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match • Private Medical Insurance for the employee • Ongoing opportunities for career development in a rapidly expanding work environment • Succession planning and internal promotions • Education allowance • Wellness activities - Social activities eg. Padel, Summer Events