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Viatris - Senior Statistician (m/f/d)

Summary

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

As a Senior Statistician at Viatris, you will take a leading role in designing clinical studies, guiding statistical strategy, and ensuring that statistical deliverables meet the highest scientific and regulatory standards. You will partner closely with clinical science, clinical operations, regulatory teams, and external CROs across multiple therapeutic areas.

About the role

Key responsibilities:

Provide statistical and methodological input into Clinical Development Plans and protocols.
Define methodologies, endpoints, and sample size calculations.
Write and review statistical protocol sections.
Lead statistical oversight for outsourced studies.
Review Statistical Analysis Plans, TFLs, and participate in Blind Data Reviews.
Support regulatory submissions, including responses to health authority queries.
Lead integrated analyses, meta-analyses, and data exploration.
Collaborate with internal teams and oversee CRO statisticians.
Contribute to publications and publication strategy

Skills/Experience:

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

MSc or PhD in Statistics, Biostatistics, or related field.
Significant level of experience within Pharmaceutical Company, CRO or required
Expertise in statistical inference, experimental design, and clinical trial methodology
Strong understanding of ICH guidelines and regulatory requirements
Solid understanding & implementation of CDISC requirements for regulatory submissions
Effective written and oral communication skills / effective communicator: able to explain methodology and decisions to non-statisticians.
Ability to prioritize with strong time management skills and pro-active
Experience in oversight with a CRO is a plus
Experience contributing to FDA/EMA drug approvals preferred
Experience in R programming is a plus

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.