Sofiane B.

I collaborated with statistical experts to provide advanced statistical expertise for clinical and non-clinical vaccine development, ensuring data-driven, quantitative decision-making.

End-to-End Statistics: Managed the statistical activities related to the development, validation, and lifecycle of various clinical products and assays.

Study Design & Reporting: Planned Design of Experiments (DoE), executed complex data analyses, and authored comprehensive statistical reports and documentation packages.

Scientific App Development: Supervised a team of 4 developers to build and deploy interactive scientific Shiny applications utilizing R and Python.

Leadership & Mentorship: Prepared, planned, and delivered formal training and webinars to coach both statisticians and non-statisticians across the organization.

I provided comprehensive statistical support across the entire lifecycle of products, processes, and analytical methods to drive quality control and manufacturing excellence.

Cross-Functional Analysis: Worked with multidisciplinary task forces to drive risk/benefit assessments, design experimental studies, and interpret complex data to resolve manufacturing investigations and troubleshooting.

Regulatory Compliance & Reporting: Authored and communicated rigorous technical reports, procedures, and presentations within a strict GxP environment, ensuring full compliance with FDA, ICH, and internal corporate guidelines.

Mentorship & Coaching: Dedicated time to training, supporting, and coaching less experienced statisticians to elevate the team's overall analytical capabilities and standards.

Provide a subject matter expertise to manufacturing and quality control department: