At a Glance
- Tasks: Support CMC projects with statistical analysis and collaborate with cross-functional teams.
- Company: Join Cytel, a leader in pharmaceutical innovation and data analysis.
- Benefits: Remote work, competitive salary, and continuous training opportunities.
- Other info: Exciting opportunity for career growth in a dynamic environment.
- Why this job: Make a real impact on drug development and patient treatment.
- Qualifications: M.S. in Biostatistics or related field, with R programming skills.
The predicted salary is between 60000 - 80000 £ per year.
An experienced Biostatistician with in-depth Bayesian analysis experience and exposure to Chemistry, Manufacturing, and Controls (CMC) data analysis. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be.
We are seeking a highly motivated Biostatistician to support CMC projects across the drug development lifecycle. The ideal candidate will have a strong foundation in statistical methodologies and programming and will play a critical role in analyzing complex manufacturing data to ensure product quality, consistency, and regulatory compliance.
Responsibilities:- 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.
- Ensure quality and compliance with internal standards and regulatory guidelines (e.g., FDA, EMA, ICH).
To be successful in this position you will have:
Required Qualifications:- M.S. or higher degree in Biostatistics, Statistics, or a related quantitative discipline.
- 2+ years 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.
Principal Biostatistician FSP - Chemistry, Manufacturing and Control in London employer: Cytel Inc
Cytel is an exceptional employer that prioritises employee growth and development, offering extensive training and support to ensure your success as a Principal Biostatistician. With a collaborative work culture embedded within a leading global pharmaceutical client, you will have the opportunity to drive innovation in patient treatment while enjoying the autonomy and ownership of your projects. Located in London, you will benefit from a vibrant city atmosphere, fostering both professional and personal enrichment.
