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Senior Statistician (m/f/d)

Key Facts

Remote From: 
United Kingdom, Netherlands, Germany
Full time
English

Other Skills

  • Non-Verbal Communication
  • Leadership
  • Time Management
  • Proactivity
  • Prioritization

Roles & Responsibilities

  • MSc or PhD in Statistics, Biostatistics, or related field
  • Significant experience in a Pharmaceutical Company or CRO
  • Expertise in statistical inference, experimental design, and clinical trial methodology
  • Strong understanding of ICH guidelines and regulatory requirements, with experience implementing CDISC for regulatory submissions

Requirements:

  • Provide statistical and methodological input into Clinical Development Plans and protocols, including defining methodologies, endpoints, and sample size calculations
  • Write and review statistical protocol sections; lead statistical oversight for outsourced studies; review SAPs, 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

Job description

Mylan Pharma UK Limited

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.

We do so via: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 
 

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 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.

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

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 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. 

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-responsibility  

At 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.

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