Full-Time Pharmaceutical Statistician

Full-time, permanent position working a 36.5-hour week, Monday - Friday 08:00 - 16:30.

Home-based in the UK, but overseas applicants considered.

Purpose: Provide expert statistical applications and technical support to commercial products across multiple Client sites and external manufacturing partners, in accordance with Good Manufacturing Practice (GMP).

Responsibilities:

• Support statistical activities ensuring delivery to standards, quality, and time.
• Provide statistics/modeling support and expertise related to drug product formulation, manufacture, process engineering, devices, packaging, and analytical testing.
• Handle statistical considerations during technical and analytical transfers, including risk assessments and change management programs.
• Support drug product shelf-life assessments through stability data trending.
• Support product review via CPV to ensure product robustness.
• Apply DOE techniques to aid understanding and improvements.
• Identify and drive quality, regulatory, improvement, and productivity activities.
• Leverage standardization to maximize global data integration and interpretability.

Qualifications:

• MSc/PhD in Statistics, Mathematics (substantial statistical component), or recognized equivalent to MSc Statistics.
• Experience in CMC Documentation is ideal.
• Understanding and practical application of key statistical concepts (equivalence and significance tests, sampling strategies, sample size determination, DOE, SPC).
• Experience with statistical modeling and data analysis; programming with relevant computational tools (R, Python, SAS, or similar).
• Knowledge of technical and regulatory requirements.
• Excellent verbal and written communication skills; proven ability to build strong relationships.
• Good understanding of OSD product lifecycle (late-stage development, launch, commercial).

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