Senior Director Biostatistics

Viatris; Kempten (Allgäu); Vor Ort; EUR 150.000 - 190.000; Vollzeit

Zusammenfassung

Viatris seeks a Senior Director Biostatistics to lead strategic statistical programs across global clinical development, shaping study design, regulatory submissions and lifecycle decisions. You will lead a small global team of statisticians, mentor staff, and collaborate with cross-functional partners to ensure quality and regulatory compliance while advancing biostatistics within the organization.

Proven track record in Phase II-IV trials and regulatory interactions, with expertise in SAS, R

Qualifikationen

• PhD or Master's degree in Statistics/Biostatistics/Mathematics or related field.
• Substantial clinical drug development experience in pharma/biotech/CRO.
• Experience leading statisticians in a global environment.
• Proven record of collaboration on external publications preferred.

Aufgaben

• Provide strategic statistical leadership for clinical programs from design to regulatory submissions.
• Lead, inspire, and coach a small global team of statisticians.
• Design, analyze, interpret, and communicate trial data.
• Review protocols and SAPs and guide regulatory submissions.
• Ensure quality, regulatory compliance, and timely delivery of statistics deliverables.
• Partner with cross-functional stakeholders and contribute to publications/presentations.

Kenntnisse

Strategic leadership

Biostatistics expertise

Mentoring / coaching

Regulatory submissions

Collaboration across functions

Ausbildung

PhD or Master's in Statistics/Biostatistics/Mathematics

Tools

SAS

R

CDISC SDTM/ADaM

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.