For one of our clients located in Wavre, I’m actively looking for a Non-Clinical/Industrial Statistician.
- Do you hold a Master Degree in Statistics, Mathematics or related field?
- Do you have at least 3 years’ experience as a statistician in the field of pharmaceutical statistics?
- Are you fluent in French and English?
Then you might be the candidate we are looking for. Don’t hesitate and apply now!
As Non-Clinical/Industrial Statistician you will work in a team of statistical experts to develop advanced statistical programs and provide statistical support to the Manufacturing and Quality organization. You will collaborate in investigation and remediation / improvement programs regarding assay and process robustness. You will advise on and develop new statistical methodologies to be used in support of Industrial Operations.
- Within the context of industrial operations, you will define, recommend and deliver statistical analysis such as :
- Six sigma analysis to assess process performance
- Designs of experiments to assess the effect of controlled factors on process
- Multivariate analyses for process / method understanding and optimization
- Measurement system analysis, tolerance intervals, stability data analysis to understand main sources of process/method variation/noise
- Statistical process control, breakpoint analysis for process/method control
- Validation and transfer of analytical methods to assess and / or improve product quality and process robustness
- You write statistical presentations / reports of performed studies within a GMP compliant environment in alignment with current ICH / FDA guidelines and SOPs
- You act as major contributor to provide statistical guidance and methodology for one or more project teams, investigations and / or trouble shooting. Reports results and conclusions back to project teams and stakeholders
- You support, train and coach less experienced statisticians in the group and organization
- You support improvement of data collection process to enable quick and reliable data analysis and improving quality of data (data integrity) ; interacts with Manufacturing sites and QC’s to align data evaluation methods
- You contribute to the development of new statistical approaches and automatized tools to provide statistical evaluation
- You participate actively to the GIO/QC statistical community and functional teams aiming at exchanging best practices and view amongst experts
- You hold a Master Degree in Statistics, Mathematics or related field
- You have at least 3 years of experience as a statistician in the field of pharmaceutical statistics, with experience in manufacturing and/or quality control (QC) operations
- You have good command of MS Office, R, SAS, and / or other statistical packages or programming language
- You have good communication and writing skills
- You are fluent in French and English
- You have experience in statistics applied to biological manufacturing processes and/or QC tests
- You have knowledge of pharmaceutical regulatory environment, ICH and USP guidelines
- You are motivated and have entrepreneurship
- You have problem solving skills: this is a key element to the role. Statisticians deal with a wide variety of issues met by the business, and have to convert the business issue into a statistical problem to be solved by statistical knowledge and techniques.
- The statistician interacts with a wide panel of people, at different levels of hierarchy, both internal and external. He has to understand and integrate the business needs, with the technical details specific to each topic, and deliver statistical support while ensuring his messages are clear regardless of the complexity of the analyses he could perform.
+32 10 68 53 30