Principal Statistician

Viatris; Kempten (Allgäu); Vor Ort; EUR 65.000 - 85.000; Vollzeit

Benefits dieser Stelle

Competitive salaries

Career progression opportunities

Work-life balance initiatives

Zusammenfassung

Viatris in Kempten (Allgäu) is looking for a Principal Statistician to lead statistical strategy in clinical studies. You will partner with various teams to support drug development, ensuring compliance with regulatory standards while applying advanced statistical techniques.

The ideal candidate holds an MSc or PhD in relevant fields, with extensive experience in late-phase trials and proficiency in statistical software like SAS and R. Join us to impact lives positively in a supportive work environment.

Qualifikationen

• Extensive involvement in late-phase trials and regulatory submissions.
• Strong understanding of ICH guidelines and regulatory requirements.
• Expert proficiency in SAS and/or R.

Aufgaben

• Provide statistical leadership for Phase 2/3 and late-stage development.
• Serve as primary statistical authority for pivotal clinical trials.
• Ensure compliance with ICH guidelines, GCP, and global regulatory requirements.

Kenntnisse

Statistical inference

Experimental design

Clinical trial methodology

Communication skills

Time management

SAS

R

Ausbildung

MSc or PhD in Statistics, Biostatistics or related field

Tools

SAS

R

Jobbeschreibung

Mylan Pharma UK Limited

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.

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

• 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)

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.

Viatris is an Equal Opportunity Employer.