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Embark on an exceptional adventure with a global biopharmaceutical company, driven by an unwavering passion to meet the crucial needs of people affected by serious diseases.
Embark on an exceptional adventure with a global biopharmaceutical company, driven by an unwavering passion to meet the crucial needs of people affected by serious diseases.
We are looking for a CMC Statistician to join our team responsible for statistical support in process development, analytical methods, and commercial monitoring within the company. This role involves working on a variety of projects ranging from preclinical phases to marketed products.
...We are looking for a CMC Statistician to join our team responsible for statistical support in process development, analytical methods, and commercial monitoring within the company. This role involves working on a variety of projects ranging from preclinical phases to marketed products.
Your main activities as CMC statistician will be :
- Statistical Support for Development: Involved in all stages of projects (from preclinical to clinical phases 1, 2, 3, and marketed products).
- Managing Multiple Requests: Handle several requests simultaneously, which may last from a few hours to several days, depending on complexity.
- Data Analysis and Reporting: Perform detailed statistical analyses and write corresponding reports. Some analyses may be reviewed by another statistician.
- Use of R and SAS: Proficiency in R and SAS software for data processing and statistical code tracking.
- Quality Monitoring and Methodology: Collaborate closely with scientists to ensure the quality of work and the application of appropriate statistical methods, particularly through Design of Experiments (DOE).
- Collaboration with Internal Departments: Interact with various departments such as development, manufacturing, and commercial to meet statistical needs, ask the right questions, and ensure the relevance of analyses.
The requirements for this position of Logistics Compliance Specialis are: :
Qualifications - Master Degree
Required Skills
Experience in the pharmaceutical industry is a must.
A blend of QA mindset and supply chain expertise: working knowledge of GMP/GDP regulations.
Experience implementing procedural control frameworks.
Familiarity with audit/inspection protocols.
Understanding of supply chain fundamentals, from long-term demand planning to patient distribution, including tools, terminology, and techniques.
Strong team spirit and ability to integrate into an existing team.
Languages: Fluency in French and English.
Preferred Skills
May involve products in launch phases or lifecycle management. As products evolve, new routes, destinations, and regulations must be considered.
A strong quality mindset is essential since the team is subject to internal and external GDP audits.
New documentation requirements mean the candidate will need to perform quality management reviews.
Product Shipping Qualification: participate in regular project meetings with global project teams.
Ensure shipping aspects are appropriately covered in alignment with project goals.
Quality Activities: prepare for inspections and audits (internal/external). Dedicate time to ensuring compliance with GDP requirements and inspection readiness.
Team Support: attend regular meetings with the Quality team to provide updates and align priorities.
For this position of Logistics Compliance Specialis, we offer you an attractive salary with the following benefits :
A rate as a freelancer is also possible.