Senior Director Biostatistics
Level inferred from job title
Job description
Senior Director Biostatistics at Viatris, providing strategic statistical leadership for clinical development programs and leading a small global team of statisticians. The role shapes statistical strategy for study design, regulatory submissions and key development decisions.
At a glance
- Work mode
- Remote · Germany, Netherlands, UK
What you'll do
- Provide strategic statistical leadership for clinical development programs and studies from design through regulatory submissions and lifecycle management.
- Lead, inspire, and coach a small global team of Statisticians.
- Lead the statistical design, analysis, interpretation and communication of clinical trial data.
- May act as a senior Principal Statistician for key development projects when required
- Review protocols, SAPs, CSRs, and provide guidance on regulatory submissions, briefing documents and responses to requests from health authorities.
- Oversee statistical deliverables, ensure quality, consistency and timely execution.
- Ensure compliance with regulatory requirements, GCP, ICH guidelines and company standards.
- Partner with cross-functional stakeholders and represent Biostatistics in strategic discussions.
- Drive capability building and innovation to meet current and future business needs
- Increase the visibility and impact of Biostatistics internally and externally through joint authorship on publications and presentations.
What we're looking for
- The ideal candidate is an inclusive people leader with a proactive and collaborative mindset, and comfortable operating in a complex, cross functional environment and able to lead by example as hands-on senior principal statistician.
- PhD or Master's degree in Statistics, Biostatistics, Mathematics, or related field.
- Substantial experience of clinical drug development within pharmaceutical, biotechnology, or CRO
- Extensive biostatistical experience as project statistician or principal statistician within the pharmaceutical industry across multiple therapeutic areas
- Strong experience supporting Phase II–IV clinical trials and regulatory submissions.
- Experience leading, mentoring and developing statisticians in a global pharma or CRO environment fostering scientific excellence.
- Deep understanding of clinical trial statistical methodologies.
- Proficiency in SAS and/or R
- Knowledge of CDISC standards including SDTM and ADaM and electronic submission standards and regulatory review processes.
- A thorough understanding of global regulatory submission expectations, and a proven record of direct interaction with regulatory agencies at a senior level.
Nice to have
- A demonstrable record of collaboration on external publications preferred.
Your team
Biostatistics
Benefits
An inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others
- Benefits
Apply
About Viatris
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. We provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
Mission
Empower people worldwide to live healthier at every stage of life
Key facts
- healthcare
- Supplying high-quality medicines to approximately 1 billion patients around the world annually
- Included on number of award lists