Nos offres d'emploi

Non-Clinical Statistician Engineer (M-F)


Belgique

CVO/BE/ING/1031


To support our development, we are looking for :

Non-Clinical Statistician Engineer (M-F)

Permanent contract

Responsibilities
Environment:
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.

Tasks and responsibilities:

? 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 GIO/QC statistical community and functional teams

Qualifications/Skills
 Master Degree in (Bio)Statistics or scientific background with relevant statistical background
 Experiences 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.
 Knowledge of pharmaceutical regulatory environment, ICH and USP guidelines.
 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.
Good command of MS Office, R, SAS, and / or other statistical packages or programming language.
Bilingual French and English

OUR OFFER
 An international Leader Company in the Engineering, Validation and Quality sector, which offers you interesting project.
 A strong corporate culture ensuring a personal and professional blooming and self-fulfillment.
 Overall trainings and a personal career management.
 A good salary package with a lot of extra legal advantages.

Don’t hesited to send us your CV via the web site

publication date : 01/03/2019

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