Pharmaceutical Statistician, Manchester
Ireland 9 hours ago
Job Description
Title: Pharmaceutical Statistician
Location: UK, France, Spain, DACHs, Netherlands, Sweden, Italy and Ireland - REMOTE
Duration: Permanent
Our client is looking is for a Pharmaceutical Statistician to support statistical activities across various aspects of drug product development and manufacturing.
Responsibilities:• Provide statistical and modeling support for drug product formulation, manufacturing processes, devices, packaging, and analytical testing to ensure quality and timeliness of project delivery.
• Oversee statistical considerations during technical and analytical transfers, including conductingrisk assessments and managing change programs to ensure smooth transitions.
• Contribute to drug product shelf-life assessments through the trending and analysis of stability data to ensure product longevity and performance.
• Support the Product Review process (CPV) to assess product robustnessand make recommendations for ongoing improvements
• Apply statistical thinking and methodologies to address and resolve practical issues encountered in development, manufacturing, or testing processes.
• Utilize DOE techniques to enhance process understanding, identify variables, and drive improvements.
• Lead or participate in initiatives aimed at driving quality, regulatory, and productivity improvements across processes.#
• Maximize the integration and interpretability of global data by leveraging standardization practices.
Requirements:
• MSc or PhD in Statistics, Mathematics (with a substantial statistical component), or an equivalent qualification (e.g., MSc in Statistics)
• Experience with Chemistry, Manufacturing, and Controls (CMC) documentation is highly preferred
• Strong understanding and practical application of key statistical concepts such as equivalence andsignificance tests, sampling strategies, sample size determination, Design of Experiments (DOE), Statistical Process Control (SPC), etc.
• Proven experience in statistical modeling and data analysis, with proficiency in relevant computational tools such as R, Python, SAS, or similar
• Solid understanding of technical and regulatory requirements pertinent to the field of drug product development and manufacturing
• In-depth knowledge of the Oral Solid Dose (OSD) product life-cycle, from late-stage development through to launch and commercial
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Title: Pharmaceutical Statistician Location: UK, France, Spain, DACHs, Netherlands, Sweden, Italy and Ireland - REMOTE Duration: Permanent Our client is looking is for a Pharmaceutical Statistician to support statistical activities across various...