Principal Statistician

1100 Mylan Pharmaceuticals Inc.; United Kingdom; On-site; GBP 60,000 - 85,000; Full time

Benefits offered by this job

Competitive salaries

Career progression opportunities

Work-life balance initiatives

Job summary

1100 Mylan Pharmaceuticals Inc. seeks a Principal Statistician to lead statistical strategy for late-stage drug development. This role involves designing clinical studies and ensuring deliverables meet scientific standards. The ideal candidate will support regulatory submissions and collaborate with cross-functional teams.

The position demands an MSc or PhD in Statistics, extensive experience in trials, and proficiency in statistical software like SAS and R. Join Viatris and contribute to impactful healthcare outcomes.

Qualifications

• Extensive involvement in late-phase trials and regulatory submissions.
• Strong understanding of ICH guidelines and regulatory requirements.
• Ability to prioritize with strong time management skills.

Responsibilities

• Provide statistical leadership for Phase 2/3 and late-stage development.
• Serve as the primary statistical authority for pivotal clinical trials.
• Lead integrated analyses, meta-analyses, and data exploration.

Skills

Statistical inference

Experimental design

Clinical trial methodology

SAS proficiency

R proficiency

Education

MSc or PhD in Statistics or Biostatistics

Tools

SAS

R

Job description

## Principal StatisticianApplylocations: Sandwich, England, United Kingdom: Germany Remote Office: Netherlands Remote Officetime type: Full timeposted on: Posted Todayjob requisition id: R5666573Mylan Pharma UK LimitedViatris 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.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.**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 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. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion**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, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibilityAt Viatris, we offer 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. Viatris is an Equal Opportunity Employer.Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.