We bring breakthrough pioneering therapies to patient with life threatening diseases.
Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of cell-based therapies. Our ambition is to develop a unique immunotherapeutic approach to offer new treatment options to cancer patients. Our team is currently focusing on the development of a new T-cell therapy that has the potential to target and destroy 80% of cancer types.
Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.
Based in Europe and in the U.S., Celyad offers a nice working environment as well as the opportunity to interact with colleagues and stakeholders involved at each step of the product development. Our Company surrounds itself with the best industrial and academic partners (Mayo Clinic, Dartmouth College, ONO Pharmaceutical) to explore the full potential of its technological platform.
At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?
Great! Celyad is looking for an enthusiastic:
The successful candidate will be based in Mont-Saint-Guibert (BE).
Role & Responsibilities
- Represent the statistics function in support of clinical studies, generally supporting multiple studies/programs at a time
- Oversees internally resourced biostatistics activities for early-stage clinical studies, providing guidance and direction to support the process for successful statistical analysis and interpretation
- Provide statistical input to development and submission plans, and in support of regulatory submissions
- Provide statistical support with minimal supervision in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables
- Implement project level database (including derived database), analysis and reporting standards
- Provide suggestions to achieve high quality databases and specifications by working with CRO Data Management
- Program and generate study-level analysis and reporting activities (eg, tables, listings, graphs)
- Review and approve key statistical deliverables
- Escalate issues to management as appropriate
- Consider and evaluate alternative analysis methodology and data presentation techniques
- Support development and implementation of departmental standards and process improvements
Qualifications & Experience
- PhD in statistics or biostatistics or equivalent with minimum of 1 year of relevant experience or MS in statistics or biostatistics or equivalent with minimum of 3 years of relevant experience
- Good knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data and presentation practices
- General knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents
- Good knowledge of statistical programming languages (including SAS), software. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products)
- Oncology experience is strongly preferred
Skills & Competencies
- Very strong attention to details
- Work precisely as per procedures, rules and regulations
- Objective and analytical
- Planning & Organizing skills
- Team spirit and ability to work both independently and across-functional team
- Strong communication skills
- Hands-on attitude
- Work from the Celyad office, with flexible work schedule/WFH ~ 2 days/week)
For more information about this position or about the Company, please contact us by email at email@example.com