Senior Director Biostatistics

Viatris; Amstelveen; Vor Ort; EUR 180.000 - 240.000; Vollzeit

Zusammenfassung

Viatris, a global healthcare company, seeks a Senior Director Biostatistics to shape the statistical strategy for innovative clinical development programs and regulatory submissions. You will lead a global team, influence study design and key development decisions, and ensure high-quality statistical deliverables.

The role requires advanced degrees in statistics and substantial biostatistics experience, with a proven ability to collaborate with regulators and cross-functional partners.

Qualifikationen

• PhD or Master’s in statistics, biostatistics or related field.
• Extensive clinical drug development experience in pharma/biotech/CRO.
• Proven track record mentoring statisticians in a global setting.

Aufgaben

• Provide strategic statistical leadership for development programs and submissions.
• Lead, inspire and coach a global team of statisticians.
• Lead design, analysis, interpretation and communication of trial data.
• Oversee regulatory submissions guidance and deliverables.
• Collaborate with cross-functional stakeholders and regulators.
• Drive capability building and innovation in Biostatistics.
• Increase visibility through publications and joint presentations.

Kenntnisse

Statistical leadership

SAS or R

CDISC SDTM/ADaM

Regulatory interactions

Ausbildung

PhD or MSc in Statistics/Biostatistics/Mathematics

Tools

SAS

R

CDISC standards

Jobbeschreibung

Mylan Pharma UK Limited

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. With a mission to empower people worldwide to live healthier at every stage of life, 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.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference, and here’s how the Senior Director Biostatistics role will make an impact:

This role offers the opportunity to shape the statistical strategy behind innovative clinical development programs, directly influencing study design, regulatory submissions, and key development decisions, while leading and developing a global team of statisticians and strengthening the strategic impact of Biostatistics across the organization.

Key responsibilities for this role include:

• 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.

The minimum qualifications for this role are:

• 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.
• A demonstrable record of collaboration on external publications preferred.

Technical Skills

• 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.

At Viatris, we offer 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.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

At Viatris, we offer 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.

Viatris is an Equal Opportunity Employer.