About Sofiane
French
Native or bilingual
English
Fluent
Arabic
Native or bilingual
Experience
- GSKPrincipal StatisticianSeptember 2020 - Today (5 years and 9 months)Rixensart, BelgiumI'm working within the Biostatistics and Statistical Programming (BSP) department to provide statistical expertise to non-clinical and clinical vaccine development. I'm in charge to follow the statistical activities related to development, validation and lifecycle of several clinical assays.• Propose design of experiments, analysis and interpretation of data and reporting.• Deliver fit-for-purpose solutions, keep the methodologies up to date and aligned with guidance.• Coordinate the different deliverables from the assays in alignment with lab priorities, project strategy and regulatory requirements.• Contribute to maintain the quality framework (validation of macros, SOP…).
- GSKResearch Statistics ManagerJanuary 2017 - August 2020 (3 years and 7 months)BelgiumWorking in a team of statistical experts to provide statistical support for all aspects of quality control and manufacturing statistics during the life cycle of product, process and analytical method.• Collaborate to multidisciplinary team (task forces, working groups, team projects, troubleshooting / investigations) to provide input to risk/benefit assessment enhancing decision and to provide statistical expertise to plan, analyze and interpret outcomes from experimental studies or problems aligned with project objectives.• Document, report and communicate plans, results and conclusions in the form of technical reports, procedures and presentations within a GXP compliant environment and in compliance with current guidelines from regulatory authorities (e.g. ICH, FDA) and GSK SOPs.• Support training and coaching to less experienced statisticians in the group and organization.
- GSKConsultant Non-Clinical/Industrial StatisticianJanuary 2014 - January 2017 (3 years)Wavre, BelgiumProvide a subject matter expertise to manufacturing and quality control department:• Statistical analysis to assess process performance and consistency• Design of experiment to assess the effect of controlled factors on process• Comparability assessment• Statistical process control and change-point analysis for process/method.
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Education
- Master of ScienceUniversité Paris DESCARTES2013Master of Science (MSc), Mathematics and Statistics
- Master of Arts in StatisticsHigh National School of Statistics and Applied Economics2011Engineer in applied statistics