Specialist Biostatistics CQC CoTPE
- Master Degree in (Bio)Statistics or scientific background with relevant statistical background
- 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
- Experience in statistics applied to biological manufacturing processes and/or QC tests
- Good command of MS Office, R, SAS, and / or other statistical packages or programming language
- Good communication and writing skills
- Strong command of English and/or French, AND willingness to achieve fluency in both.
- Knowledge of pharmaceutical regulatory environment, ICH and USP guidelines
- Motivation and entrepreneurship
Problem solving 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.
Work in a team of statistical experts to develop advanced statistical programs and provide statistical support to the to the Manufacturing and Quality organization.
Collaborate in investigation and remediation / improvement programs regarding assay and process robustness.
Advise on and develop new statistical methodologies to be used in support of Industrial Operations.
- Within the context of industrial operations, 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
- Writing of statistical presentations / reports of performed studies within a GMP compliant environment in alignment with current ICH / FDA guidelines and GSK SOPs
- Acts 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
- Supports, training and coaching to less experienced statisticians in the group and organization
- Supports 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
- Contributes to the development of new statistical approaches and automatized tools to provide statistical evaluation
- Participate actively to the various statistical community and functional teams aiming at exchanging best practices and view amongst experts
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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