Principal Biostatistician – Chemistry, Manufacturing and Control

Clinical Outcomes Solutions

Biostatistician supporting CMC projects across the drug development lifecycle. Engaging with teams to analyze manufacturing data ensuring product quality and compliance.

Posted 7/3/2026full-timeRemote • 🇬🇧 United KingdomLeadWebsite

About the role

Key responsibilities & impact

Provide statistical support for CMC-related studies, including formulation development, stability studies, process validation, and analytical method validation.
Collaborate with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs, to develop and implement appropriate statistical strategies.
Design and analyze experiments using linear mixed models, particularly for stability and variability analyses.
Perform statistical modeling, data visualization, and simulations using R programming.
Experience with Bayesian methods preferred.
Ensure quality and compliance with internal standards and regulatory guidelines (e.g., FDA, EMA, ICH).

Requirements

What you’ll need

PhD in Biostatistics, Statistics, or a related quantitative discipline.
A strong interest in supporting CMC or related manufacturing/analytical projects in a pharmaceutical or biotechnology setting.
Strong proficiency in R programming for statistical modeling, analysis, and visualization.
Solid understanding and practical application of linear mixed models.
Excellent communication and collaborative skills to work effectively across teams.
Exposure to or hands-on experience with Bayesian statistics and its application in industrial settings.
Familiarity with a wide variety of statistical transformations and distributions, appropriate for CMC data.

Benefits

Comp & perks

Consistent training
Development
Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Statistical ModelingData VisualizationSimulationsLinear Mixed ModelsStatistical TransformationsStatistical AnalysisBayesian MethodsProcess ValidationAnalytical Method ValidationFormulation Development

Soft Skills

Excellent CommunicationCollaborative Skills