Pharmaceutical Statistician Job

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Pharmaceutical Statistician

Job Posted: 11 days ago

  • Salary: Competitive

    Job Type: Permanent

  • Location: Manchester

Expire in: 17 days

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 conducting risk 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 robustness and 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 and significance 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 phase
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