At a Glance
- Tasks: Lead statistical strategy for clinical studies and ensure high-quality deliverables.
- Company: Viatris, a global healthcare company making a real impact on health.
- Benefits: Competitive salary, inclusive culture, career progression, and work-life balance.
- Other info: Join a diverse team dedicated to empowering healthier communities worldwide.
- Why this job: Make a difference in global healthcare while advancing your statistical expertise.
- Qualifications: MSc or PhD in Statistics/Biostatistics and experience in late-phase trials.
The predicted salary is between 80000 - 100000 £ per year.
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.
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 ideal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.
Key Responsibilities:- 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.
- 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 competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Diversity & Inclusion at Viatris:At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.
Sustainability at Viatris:Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life.
Principal Statistician in London employer: 1100 Mylan Pharmaceuticals Inc.
Viatris is an exceptional employer that fosters a collaborative and inclusive work culture, empowering employees to make a meaningful impact on global healthcare. Located in Sandwich, England, the company offers competitive salaries, excellent career progression opportunities, and a strong commitment to diversity and sustainability, ensuring that every team member can thrive both professionally and personally.
Contact Details:
1100 Mylan Pharmaceuticals Inc. Recruitment Team
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