Overview
Senior Statistician at Viatris leads statistical design and strategy for clinical studies, ensuring high scientific and regulatory quality. You partner with clinical science, operations, regulatory teams, and CROs across multiple therapeutic areas. You drive methodological input, sample size decisions, and integrated analyses while supporting regulatory submissions. The role blends leadership in outsourced studies with publication strategy to advance patient health. This is a chance to shape statistical decisions within a global biometrics team.
Leistungen / Benefits
- competitive salaries
- benefits
- career progression opportunities
- work-life balance initiatives
- inclusive environment
- equal opportunity employer
Verantwortungsbereiche
- Provide statistical 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 SAPs, 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
Zentrale Anforderungen
- MSc in Statistics, Biostatistics, or related field
- Significant experience in pharmaceutical company or CRO
- Expertise in statistical inference, experimental design, and clinical trial methodology
- Strong understanding of ICH guidelines and regulatory requirements
- Solid understanding & implementation of CDISC for regulatory submissions
- Effective written and oral communication skills; able to explain methodology to non-statisticians
- Ability to prioritize with strong time management and pro-active approach
- Experience with CRO oversight is a plus
- Experience contributing to FDA/EMA drug approvals is preferred
- Experience in R programming is a plus
- effective written and oral communication
- pro-active
- time management
- statistical inference
- experimental design
- clinical trial methodology
Principal Statistician in Berlin Arbeitgeber: Viatris
Viatris ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern eine verantwortungsvolle Außendienstposition mit hoher Eigenständigkeit bietet. In einer offenen und wertschätzenden Unternehmenskultur haben Sie die Möglichkeit, Ihre Ideen aktiv einzubringen und umzusetzen, während Sie von einem engagierten Team unterstützt werden. Zudem profitieren Sie von attraktiven finanziellen Zusatzleistungen, einem Firmenwagen sowie hervorragenden Karrierechancen in einem vielfältigen und integrativen Umfeld.
