At a Glance
- Tasks: Lead statistical strategy for late-stage clinical studies and ensure high-quality deliverables.
- Company: Viatris, a global healthcare company improving access to quality medicines.
- Benefits: Competitive salary, comprehensive benefits, career progression, and work-life balance.
- Other info: Join an inclusive workplace that values diversity and fosters career growth.
- Why this job: Make a real impact in drug development and collaborate with diverse teams.
- Qualifications: MSc or PhD in Statistics/Biostatistics and extensive experience in late-phase trials.
The predicted salary is between 80000 - 100000 £ per year.
Company Overview
Viatris is a global healthcare company committed to improving access to high‑quality medicines. We partner with patients, clinicians, and regulatory authorities to deliver innovative therapies worldwide.
Role Summary
As a Principal Statistician, you will lead the design and statistical strategy for late‑stage clinical studies, ensuring that all deliverables meet the highest scientific and regulatory standards. You will work closely with clinical science, operations, regulatory, and external CROs to support drug development across multiple therapeutic areas.
Key Responsibilities
- Provide statistical leadership for one or more indications or compounds, focusing on Phase II/III and late‑stage development.
- Serve as the primary statistical authority for pivotal clinical trials and regulatory submissions.
- Own high‑quality statistical deliverables, including 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 when appropriate.
- Act as a subject‑matter expert in internal governance and external scientific forums.
- 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.
- Share best practices and knowledge internally.
Qualifications
- MSc or PhD in Statistics, Biostatistics, or a related field (PhD preferred).
- Extensive experience in late‑phase trials and regulatory submissions.
- Significant experience within a pharmaceutical company or CRO.
- Expertise in statistical inference, experimental design, and clinical trial methodology.
- Strong understanding of ICH guidelines and regulatory requirements.
- Implementation of CDISC requirements for regulatory submissions.
- Excellent written and oral communication skills with the ability to explain methodology to non‑statisticians.
- Strong prioritization, time‑management, and pro‑active approach.
- Experience overseeing CRO statisticians.
- Proven track record of contributing to FDA/EMA drug approvals.
- Expert proficiency in SAS and/or R (experience with both is a plus).
Benefits
Competitive salary, comprehensive benefits package, opportunities for career progression, work‑life balance initiatives, and a collaborative, inclusive work environment.
Equal Opportunity Employer
Viatris is an Equal Opportunity Employer. We value diversity and are committed to fostering an inclusive workplace.
Principal Statistician in Kent employer: 1100 Mylan Pharmaceuticals Inc.
Viatris is an exceptional employer, offering a dynamic and inclusive work environment where you can thrive as a Principal Statistician. With a commitment to employee growth, competitive salaries, and a comprehensive benefits package, we prioritise work-life balance while empowering our team to lead innovative drug development initiatives. Join us in making a meaningful impact on global healthcare by collaborating with diverse professionals dedicated to improving access to high-quality medicines.
Contact Details:
1100 Mylan Pharmaceuticals Inc. Recruitment Team
