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.

Job Responsibilities:

• 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.

Key Skills:

• 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.

Requirements:

• 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.

Apply now:

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.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.