Mathematicians, Actuaries and Statisticians

Senior Director of Biostatistics

Viatris

Amstelveen, North Holland, Netherlands

On-Site

Expert

Starts as soon as possible

posted 6 days ago

Vacancy Summary

Join Viatris as a Senior Director of Biostatistics to lead the statistical strategy for innovative clinical programs. You'll directly influence study design and regulatory submissions while developing a global team of statisticians.

Required skills

Regulatory Requirements

communication

Compliance

Innovation

Methodologies

Lifecycle Management

Clinical Development

planning

CRO

Technical Skills

Clinical Drug Development

CDISC

ADaM

SDTM

Design

Influencing

Google Cloud Platform (GCP)

Mathematics

regulatory submissions

Pharmaceuticals

requests

SAS

Healthcare

Clinical Trials

Statistical Analysis

Statistics

Strategy

Access

Interpretation

Capability Building

Guidance

execution

regulations

ACT

Make

CAN

ICH Guidelines

data

mentoring

WELL

Identity

understanding

Benefits

salaries

Standards

GAP

Mylan Pharma UK Limited Viatris is a global healthcare company that uniquely bridges the gap between generics and brands, addressing healthcare needs holistically. Our mission is to empower individuals worldwide to live healthier lives at every stage, providing access to high-quality medicines for approximately 1 billion patients annually, from birth to end-of-life care. We are proud to be recognized on various award lists for our impactful contributions.

In the role of Senior Director of Biostatistics, you will shape the statistical strategy for innovative clinical development programs, influencing study design, regulatory submissions, and key development decisions. You will lead and develop a global team of statisticians, enhancing the strategic impact of Biostatistics across the organization.

Responsibilities:

  • Provide strategic statistical leadership for clinical development programs and studies from design through regulatory submissions and lifecycle management.
  • Inspire and coach a small global team of Statisticians.
  • Oversee the statistical design, analysis, interpretation, and communication of clinical trial data.
  • Act as a senior Principal Statistician for key development projects when required.
  • Review protocols, SAPs, and CSRs, providing guidance on regulatory submissions and responses to health authority requests.
  • Ensure the quality, consistency, and timely execution of statistical deliverables.
  • Maintain compliance with regulatory requirements, GCP, ICH guidelines, and company standards.
  • Collaborate with cross-functional stakeholders and represent Biostatistics in strategic discussions.
  • Drive capability building and innovation to meet current and future business needs.
  • Enhance the visibility and impact of Biostatistics internally and externally through joint authorship on publications and presentations.

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