Principal Biostatistician – Chemistry, Manufacturing and Control

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• 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

• 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

• Consistent training • Development • Support