Senior Director, Biostatistics

Job not on LinkedIn

🔥 12 hours ago

🌐 United Kingdom, Germany, +1 more countries – Remote

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⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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Logo of Viatris

Viatris

10,000+ employees

Founded 2020

🏥 Healthcare

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Healthcare • Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

📋 Description

• Provide strategic statistical leadership for clinical development programs and studies from design through regulatory submissions and lifecycle management • Lead, inspire, and coach a small global team of statisticians • Lead the statistical design, analysis, interpretation and communication of clinical trial data • Act as a senior Principal Statistician for key development projects when required • Review protocols, SAPs, CSRs, and provide guidance on regulatory submissions, briefing documents and responses to health authority requests • Oversee statistical deliverables and ensure quality, consistency and timely execution • Ensure compliance with regulatory requirements, GCP, ICH guidelines and company standards • Partner with cross-functional stakeholders and represent Biostatistics in strategic discussions • Drive capability building and innovation to meet current and future business needs • Increase the visibility and impact of Biostatistics internally and externally through joint authorship on publications and presentations

🎯 Requirements

• PhD or Master’s degree in Statistics, Biostatistics, Mathematics, or related field • Substantial experience in clinical drug development within pharmaceutical, biotechnology, or CRO environments • Extensive biostatistical experience as project statistician or principal statistician within the pharmaceutical industry across multiple therapeutic areas • Strong experience supporting Phase II–IV clinical trials and regulatory submissions • Experience leading, mentoring and developing statisticians in a global pharma or CRO environment • Demonstrable record of collaboration on external publications preferred • Deep understanding of clinical trial statistical methodologies • Proficiency in SAS and/or R • Knowledge of CDISC standards including SDTM and ADaM • Knowledge of electronic submission standards and regulatory review processes • Thorough understanding of global regulatory submission expectations • Proven record of direct interaction with regulatory agencies at a senior level • Inclusive people leader with a proactive and collaborative mindset, comfortable operating in a complex, cross-functional environment and able to lead by example as a hands-on senior principal statistician

🏖️ Benefits

• Competitive salaries • Benefits • Inclusive environment • Equal Opportunity Employer

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