Full-Time Pharmaceutical Statistician

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

Homebased within the UK, but overseas applicants considered.

Role Purpose: Provide expert statistical applications and technical support to commercial products across multiple client sites and external manufacturing partners, adhering to Good Manufacturing Practice.

Responsibilities:

• Support statistical activities for quality, standards, and timely delivery.
• Provide statistics/modelling support and expertise for drug product formulation, manufacture, process engineering, devices, packaging, and analytical testing.
• Manage statistical considerations during technical and analytical transfers (risk assessments and change management).
• Support drug product shelf-life assessments using stability data trending.
• Support product robustness through CPV product reviews.
• Use statistical thinking for problem-solving and issue resolution.
• Apply DOE techniques for understanding and process improvements.
• Identify and drive quality, regulatory, improvement, and productivity activities.
• Maximize global data integration and interpretability through standardization.

Qualifications:

• MSc/PhD in Statistics, Mathematics (substantial statistical component), or recognized equivalent to MSc Statistics.
• Understanding and practical application of key statistical concepts (e.g., 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).
• Knowledge of technical and regulatory requirements.
• Excellent verbal and written communication skills; proven ability to build relationships.
• Good understanding of OSD product life-cycle (late-stage development to launch).

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