Provide statistical leadership for one or more indications or compounds, with a focus on Phase 2/3 and late-stage development
Serve as the primary statistical authority for assigned pivotal clinical trials and regulatory submissions
Take accountability for high‑quality statistical deliverables, including statistical and methodological input into Clinical Development Plans and Study Protocols
Respond to health authority queries and represent Viatris in statistical discussions with regulatory agencies (FDA, EMA, MHRA)
Partner with clinical and medical teams to drive evidence-based decisions, incorporating adaptive and innovative methodologies, where appropriate
May act as a subject matter expert in internal governance and external scientific forums
Confidently apply advanced modeling techniques where necessary
Lead statistical oversight for outsourced studies by reviewing Statistical Analysis Plans, TFLs, and leading Blind Data Reviews
Ensure compliance with ICH guidelines, GCP, and global regulatory requirements
Lead integrated analyses, meta-analyses, and data exploration
Contribute to publications and publication strategy
Contribute to internal best practices and knowledge-sharing activities.
About Your 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 (preferred) in Statistics, Biostatistics, or related field
Extensive involvement in late-phase trials and regulatory submissions
Significant level of relevant experience within Pharmaceutical Company or a CRO
High level of 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
Strong written and oral communication skills with the ability to effectively explain methodology, and associated decision making, to non-statisticians
Ability to prioritize, with strong time management skills, and to be pro-active
Experience in oversight of CRO statisticians (either from within a Sponsor organization or via a senior role within the CRO)
Proven experience and strong track record of contributing to FDA/EMA drug approvals
Expert proficiency in SAS and/or R (experience with both 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.
Benefits at Viatris
At Viatris, we offer a friendly working atmosphere in a global Biometrics team with co
Benefits
Health insurance
Additional Information
Mylan Pharma UK Limited
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
As a Principal 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.
You will be supporting late-stage drug development for programs across multiple therapeutic areas, and you will act as a key advisor within project teams, ensuring statistical integrity and innovation throughout the product lifecycle. This is a high impact role which requires advanced technical expertise, strategic thinking, and the ability to influence study design and regulatory strategy.
This position is deal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.
Viatris · Sandwich, UK