Within the Biostatistics & Data Management team, biostatisticians?provide statistical expertise and support in the development of prophylactic or therapeutic vaccines.
Amongst the 90 statisticians part of an international team and devoted to the?discovery and development of vaccines, an expanding team of about 10?statisticians/statistical programmers are providing statistical expertise to the cancer?immunotherapeutics clinical development.?Currently two Phase III studies are ongoing in non-small cell lung cancer and melanoma;
It's a growing team sharing and learning from each other. Creative, always?looking for new and better ways to do their job. They focus on performance but recognize there is no achievement without integrity.
As senior biostatistician in the oncology statistical team, you will :
Participate in the cancer immunotherapeutics development plan (trial designs, sample sizes, interim analysis, etc.) in collaboration with clinical development managers and safety physicians.
In particular, provide strategic, statistical, and scientific input into clinical development planning
Be responsible for the statistical designs of clinical trials, creating statistical sections for study synopses and protocols
Give your input in study set up (case report forms, database, randomization)
Explore new statistical approaches and methodologies through innovative and creative thinking
Interact with regulatory authorities
Propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans
Perform statistical analysis, run simulations and discuss with internal and external experts
Support scientific writers and clinicians to correctly interpret the statistical results and align them with the clinical report conclusions
Write the statistical sections of clinical study reports, statistical publications and prepare materials for publications and create statistical text for clinical study communication
A M.Sc. or Ph.D. degree in Biostatistics
At least 5-7 years of experience in Statistics
Good knowledge of statistical approaches applied in cancer clinical trials with a focus on survival analysis techniques
Comprehensive understanding of applied statistical principles and modeling in the?design and analysis of clinical trials
Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis
Able to easily communicate with different functions: clinicians, scientists, data
managers, scientific writers, commercials, etc. in an international, multi-cultural
Compliant with internal Standard Operating Procedures and regulatory guidelines
Proficient in SAS or other statistical software is an asset
Fluent in French and in English
We offer you a permanent contract with XPE Pharma as Consultant, a job in a Great place to work
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