Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Due to their mode of action and/or manufacturing constraints, delay in treatment effect or alternative data distribution than the standard exponential assumption are expected in time to event analysis in cancer immuno-therapies (CIT, for example in immune checkpoint inhibitor or cell therapies). In addition, long term survivor effect, also called cure fraction, may occur with those novel therapies. These specific characteristics in CIT are leading to violation of the proportional hazard assumption and standard approach for sample size calculation for time to event data is no more valid.
The intern will first perform a literature research to document all current methods available for sample size calculation for time to event data in presence of delayed treatment effect, alternative data distribution and/or cure fraction. The intern will then perform simulation using R (standalone or linked to EAST) to evaluate the operating characteristics of some of those methods. Finally, the intern will be asked to create a job aid for sample size calculation in CIT and to present a summary of the work to the Biometric data operation group.
A Ph.D. candidate or MSc candidate in Statistics /Biostatistics whose research area is concentrated on survival analysis. Excellent R programming skills, especially in writing simulation programs. Willing to learn how to use EAST (Cytel). Knowledge of MS Office products (Word, Excel, PowerPoint).
Good interpersonal, communication, writing and organizational skills. A good team player.
Development of R programs (standalone or linked to EAST) for sample size calculation. The R programs should be well documented and straightforward to use. Operating characteristics of sample size methods will be summarized with valid conclusions and recommendations. Practical applications on future phase 3 studies in CIT domain.
Not ready to apply?Join Our Talent Network
Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.