Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.
Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
The Principal Biostatistician will be responsible for implementing and executing methodological and statistical aspects of clinical development programs. In addition, the Principal Biostatistician will provide leadership and guidance on statistical matters to interdepartmental clinical and regulatory teams. This position is open within Genzyme's Rare Disease therapeutic area and provides the opportunity to contribute during a regulatory review as well as working on new and exciting clinical studies.
Qualifications for this position include the following:
- Ph.D (M.S) in biostatistics or statistics with 3+ (5+) years of experience in a clinical trial setting (biotech, pharma, CRO, academic institution)
- Excellent communication and writing skills including the ability to clearly describe advanced statistical techniques and interpret results
- Knowledge of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
- Thorough and up-to-date knowledge of advanced clinical trial statistical methodology, including time-to-event and recurrent event analysis, sequential methods, longitudinal data analysis (e.g. LME, GEE), techniques for handling missing data, nonparametric methods, Bayesian methods
- Demonstrated productivity and ability to meet timelines for deliverables such as key results and final analyses
- The ability to produce statistical documents such as publications or technical reports
- Thorough and up-to-date working knowledge of SAS and additional statistical software (e.g. R, WinBUGS, etc.)
- Understanding of clinical / regulatory concepts for at least one therapeutic area
- With some supervision, ability to formulate statistical objectives, design and analyses for complex clinical projects
- Good communication and developing negotiation skills M*
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