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Hobson Prior are currently working with a specialty biopharma organisation who are focused on the advancing and manufacturing biosimilar medicines. Our client is looking for a CMC Statistician to setup and drive the statistical strategy to all aspects across Process Product Development to enable efficient, robust, and statistically sound development and characterization of processes for biosimilars.
- Leadership role to set up statistical strategy for PPD across development life cycle.
- Establish statistical tools standards and processes to ensure all statistical analysis are performed in a consistent manner, using QbD and statistical principles to drive process improvement.
- Bring statistical support in the design of experimental protocols, realization and interpretation of statistical results analysis and their presentation.
- Harmonize statistical practices within PPD.
- Data mining / data base.
- Training and support of scientist to statistical methods.
- Bring statistical expertise to strategy meetings.
- Advise on SOPs from statistical point of view.
- Monitor industry advances in statistical methods to optimize study designs and statistical analysis methods.
- Partake to answer questions from agencies on registration dossiers.
- Contribute to successful commercial Pre-Approval Inspections, regular Audits and any other interactions with regulatory agencies as required.
- Result driven self-starter, a team player with creative ideas.
- Excellent communication (verbal and written) skills to communicate complex statistical concepts to non-statisticians and work directly with non-statisticians.
- Good organizational skills.
- Works very accurate.
- Diploma MS or PhD in statistics.
- A minimum of 5 years' experience in the field of non-clinical statistics applied to biopharmaceutical development in the following domains:
- Experimental designs (univariate, multivariate) in context of development of processes following a QbD approach.
- Stability studies, comparability studies, capability and trend analysis.
- Visualization plots, mathematical modeling and prediction profiling.
- Data mining, data bases.
- Understanding of regulatory requirements.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
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