Senior Director, Biostatistics

Viatris

. Provide strategic statistical leadership for clinical development programs and studies from design through regulatory submissions and lifecycle management .

Posted 10/8/2026full-timeRemote • United Kingdom, Germany, NetherlandsSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical leadership for clinical development, with a strong focus on biostatistical methodologies, regulatory compliance, and team mentorship. Proven ability to drive innovation and collaboration in a global pharmaceutical environment.

Highest-signal resume keywords

PhD Or Master’s Degree In StatisticsExtensive Biostatistical ExperienceProficiency In SAS And/or RKnowledge Of CDISC StandardsExperience Leading And Mentoring Statisticians

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical DesignClinical Trial AnalysisRegulatory SubmissionsStatistical MethodologiesProject Statistician ExperiencePhase II–IV Clinical TrialsQuality AssuranceData InterpretationStatistical Deliverables OversightCollaboration On Publications

Soft Skills

Inclusive LeadershipProactive MindsetCollaborationCoachingCommunication

Tools & Technologies

SASR

Industry Keywords

Clinical DevelopmentPharmaceutical IndustryBiotechnologyCRO EnvironmentGCPICH GuidelinesRegulatory AgenciesGlobal Regulatory SubmissionElectronic Submission StandardsTherapeutic Areas

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
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 health authority requests
Oversee statistical deliverables and 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

Requirements

What you’ll need

PhD or Master’s degree in Statistics, Biostatistics, Mathematics, or related field
Substantial experience in clinical drug development within pharmaceutical, biotechnology, or CRO environments
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
Demonstrable record of collaboration on external publications preferred
Deep understanding of clinical trial statistical methodologies
Proficiency in SAS and/or R
Knowledge of CDISC standards including SDTM and ADaM
Knowledge of electronic submission standards and regulatory review processes
Thorough understanding of global regulatory submission expectations
Proven record of direct interaction with regulatory agencies at a senior level
Inclusive people leader with a proactive and collaborative mindset, comfortable operating in a complex, cross-functional environment and able to lead by example as a hands-on senior principal statistician

Benefits

Comp & perks

Competitive salaries
Benefits
Inclusive environment
Equal Opportunity Employer