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 Office time type:
Praca na pełny etatposted on:
Opublikowano dzisiajjob requisition :
R5666573

Mylan Pharma UK Limited

W Viatris postrzegamy opiekę zdrowotną taką, jaką być powinna, a nie taką jaka jest. Działamy odważnie i mamy wyjątkowe uwarunkowania, dzięki czemu stanowimy źródło stabilności w świecie zmieniających się potrzeb zdrowotnych. Viatris umożliwia ludziom na całym świecie zdrowsze życie na każdym jego etapie Osiągamy to poprzez (via):
* Dostęp* – dostarczanie pacjentom wysokiej jakości leków, cieszących się powszechnym zaufaniem, w czasie i miejscu, w jakim ich potrzebują;
* Przywództwo* – podejmowanie zrównoważonych działań i opracowywanie innowacyjnych rozwiązań w celu poprawy zdrowia pacjentów; oraz
* Partnerstwo* – wykorzystanie wspólnej wiedzy w celu dostarczenia naszych produktów i usług.

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…