Strategic Statistician, Late-Stage Clinical Trials

1100 Mylan Pharmaceuticals Inc.; England; Presencial; GBP 90 000 - 130 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salaries

Inclusive environment

Global biometrics team

Resumo da oferta

Viatris is seeking a Principal Statistician to lead design and statistical strategy for late-stage programs across multiple therapeutic areas. You will partner with clinical science, operations, and regulatory teams to ensure rigorous statistics and regulatory-ready deliverables.

The role emphasizes ownership, collaboration and data-driven decision making, supporting submissions and methodological innovations within a global Biometrics team.

Qualificações

• MSc or PhD (preferred) in Statistics, Biostatistics, or related field.
• Extensive involvement in late-phase trials and regulatory submissions.
• Significant experience within Pharmaceutical Company or 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 explain methodology to non-statisticians.
• Ability to prioritise with strong time management and pro‑active attitude.
• Experience in overseeing CRO statisticians (Sponsor or CRO senior role).
• Proven experience and strong track record contributing to FDA/EMA drug approvals.
• Expert proficiency in SAS and/or R (experience with both is a plus).

Responsabilidades

• Provide statistical leadership for one or more indications with Phase 2/3 focus.
• Serve as primary statistical authority for pivotal clinical trials and regulatory submissions.
• Ensure high-quality statistical deliverables and input into CDPs and Study Protocols.
• Respond to health authority queries and represent Viatris in regulatory discussions.
• Drive evidence-based decisions with adaptive and innovative methodologies.
• Lead statistical oversight for outsourced studies and review SAPs and TFLs.
• 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 within the team.

Conhecimentos

Late-stage trials

Regulatory submissions

CDISC

ICH guidelines

SAS

R

Statistical inference

Clinical trial methodology

Communication

Formação académica

MSc/PhD in Statistics/Biostatistics

Ferramentas

SAS

R

Descrição da oferta de emprego

Viatris is seeking a Principal Statistician to lead design and statistical strategy for late-stage programs across multiple therapeutic areas. You will partner with clinical science, operations, and regulatory teams to ensure rigorous statistics and regulatory-ready deliverables.

The role emphasizes ownership, collaboration and data-driven decision making, supporting submissions and methodological innovations within a global Biometrics team.