Principal Statistician

Viatris Inc.

Job Overview

Location

Germany Remote Office; Netherlands Remote Office; Sandwich, England, United Kingdom

Job Type

Full-time

Full Job Description

📋 Description

• Lead statistical strategy for late-stage clinical development programs across multiple therapeutic areas, with primary focus on Phase 2/3 trials and regulatory submissions.
• Serve as the primary statistical authority for pivotal clinical trials, ensuring statistical integrity and alignment with global regulatory expectations.
• Provide methodological input into Clinical Development Plans and Study Protocols, driving evidence-based decisions through advanced statistical modeling.
• Represent Viatris in statistical discussions with regulatory agencies including FDA, EMA, and MHRA, responding to health authority queries and supporting drug approvals.
• Oversee statistical activities for outsourced studies by reviewing Statistical Analysis Plans (SAPs), Tables, Figures, and Listings (TFLs), and leading Blind Data Reviews.
• Ensure full compliance with ICH guidelines, Good Clinical Practice (GCP), and global regulatory requirements throughout the product lifecycle.
• Lead integrated analyses, meta-analyses, and exploratory data analyses to support clinical and regulatory decision-making.
• Contribute to scientific publications and publication strategies, ensuring statistical rigor and alignment with regulatory standards.
• Act as a subject matter expert in internal governance committees and external scientific forums.
• Mentor and guide junior statisticians and collaborate closely with clinical science, clinical operations, and regulatory teams.
• Implement and enforce CDISC standards for regulatory submissions, ensuring data quality and consistency across global studies.
• Apply advanced statistical techniques including adaptive designs, Bayesian methods, and complex modeling where appropriate to enhance trial efficiency and decision-making.
• Drive internal best practices and knowledge-sharing initiatives within the global Biometrics team to elevate statistical capabilities across the organization.
• Maintain proactive oversight of CRO statisticians, providing direction, review, and quality assurance for outsourced statistical work.
• Communicate complex statistical concepts clearly and effectively to non-statisticians, including medical, operational, and regulatory stakeholders.
• Prioritize multiple high-impact projects with strong time management and organizational skills, ensuring timely delivery of critical statistical deliverables.

🎯 Requirements

• MSc or PhD (preferred) in Statistics, Biostatistics, or related field
• Extensive involvement in late-phase clinical trials and regulatory submissions
• Significant experience within a pharmaceutical company or CRO
• Expert proficiency in SAS and/or R (experience with both is a plus)
• Strong understanding of ICH guidelines, CDISC standards, and global regulatory requirements
• Proven track record of contributing to FDA/EMA drug approvals

🏖️ Benefits

• Competitive salaries
• Inclusive and collaborative global Biometrics team environment
• Career progression opportunities
• Work-life balance initiatives

Skills & Technologies

GCP

Senior

Remote

Degree Required

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Viatris Inc.

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About Viatris Inc.

Viatris Inc. is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. It develops, licenses, manufactures, markets and distributes a broad portfolio of branded, generic, complex generic, biosimilar and over-the-counter medicines, as well as active pharmaceutical ingredients. The company operates in more than 165 countries and territories, focusing on expanding access to medicines for non-communicable and infectious diseases, driven by a Global Healthcare Gateway that leverages its supply-chain, scientific and regulatory expertise to serve patients worldwide.

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