Principal Biostatistician – Chemistry, Manufacturing and Control

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Deliver statistical assistance for CMC-related research, encompassing formulation development, stability studies, process validation, and analytical method validation.

• Work collaboratively with diverse teams, including analytical scientists, process engineers, and regulatory affairs, to devise and execute suitable statistical strategies.

• Design experiments and conduct analyses utilizing linear mixed models, specifically for stability and variability assessments.

• Carry out statistical modeling, data visualization, and simulations using R programming.

• Preference for experience with Bayesian methodologies.

• Ensure adherence to quality and compliance with internal standards and regulatory requirements (e.g., FDA, EMA, ICH).

⛳️ Requirements

• PhD in Biostatistics, Statistics, or a relevant quantitative field.

• A keen interest in contributing to CMC or related manufacturing/analytical initiatives within a pharmaceutical or biotechnology environment.

• Strong expertise in R programming for statistical modeling, analysis, and visualization.

• Comprehensive understanding and practical application of linear mixed models.

• Exceptional communication and teamwork abilities to collaborate effectively across departments.

• Exposure to or direct experience with Bayesian statistics and its industrial applications.

• Familiarity with a broad range of statistical transformations and distributions suitable for CMC data.

🏝️ Benefits

• Ongoing training

• Development opportunities

• Support