Pharmaceutical Statistician

Kenton Black Ltd; Manchester; Remote; GBP 80,000 - 100,000; Full time

Job description

Title: Pharmaceutical Statistician
Location: UK, France, Spain, DACHs, Netherlands, Sweden, Italy and Ireland - REMOTE
Duration: Permanent

Our client is looking for a Pharmaceutical Statistician to support statistical activities across various aspects of drug product development and manufacturing.

Responsibilities:

1. Provide statistical and modeling support for drug product formulation, manufacturing processes, devices, packaging, and analytical testing to ensure quality and timeliness of project delivery.
2. Oversee statistical considerations during technical and analytical transfers, including conducting risk assessments and managing change programs to ensure smooth transitions.
3. Contribute to drug product shelf-life assessments through the trending and analysis of stability data to ensure product longevity and performance.
4. Support the Product Review process (CPV) to assess product robustness and make recommendations for ongoing improvements.
5. Apply statistical thinking and methodologies to address and resolve practical issues encountered in development, manufacturing, or testing processes.
6. Utilize DOE techniques to enhance process understanding, identify variables, and drive improvements.
7. Lead or participate in initiatives aimed at driving quality, regulatory, and productivity improvements across processes.
8. Maximize the integration and interpretability of global data by leveraging standardization practices.

Requirements:

1. MSc or PhD in Statistics, Mathematics (with a substantial statistical component), or an equivalent qualification (e.g., MSc in Statistics).
2. Experience with Chemistry, Manufacturing, and Controls (CMC) documentation is highly preferred.
3. 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.
4. Proven experience in statistical modeling and data analysis, with proficiency in relevant computational tools such as R, Python, SAS, or similar.
5. Solid understanding of technical and regulatory requirements pertinent to the field of drug product development and manufacturing.
6. In-depth knowledge of the Oral Solid Dose (OSD) product life-cycle, from late-stage development through to launch and commercial phase.