Amongst the 90 statisticians part of an international team and devoted to the discovery and development of pharmaceutical products, 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. We are a growing team sharing and learning from each other. We are creative, always looking for new and better ways to do our job. We 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 • 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 communications
Experience & Knowledge o At least 5-7 years of experience in Statistics o Good knowledge of statistical approaches applied in cancer clinical trials with a focus on survival analysis techniques o Comprehensive understanding of applied statistical principles and modeling in the design and analysis of clinical trials o Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis
o Ability to easily communicate with different functions: clinicians, scientists, data managers, scientific writers, commercials, etc. in an international, multi-cultural environment o Compliance with internal Standard Operating Procedures and regulatory guidelines
o M.Sc. or Ph.D. degree in Biostatistics
ICT Skills o Proficiency in SAS knowledge or other statistical software is an asset Language Proficiency Requirements o English fluent o French is an asset