Senior Statistician (m/f/d)

Senior Statistician (m/f/d) page is loaded Senior Statistician (m/f/d)locations: Sandwich, England, United Kingdom: Germany Remote Office: Netherlands Remote Officetime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: RMylan Pharma UK LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs: Accès : En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient. Leadership : En favorisant l'évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients. Partenariat : En valorisant notre expertise collective afin de donner accès à tous à nos produits et 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 plusAt 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 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 visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d'œuvre mondiale d'environ personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l'être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu'un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d'excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.