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.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
The CQO – Stability & Statistics department designs and executes stability programs to support product expiration dating, storage and handling, shipping and patient use in compliance with industry practices and regulatory requirements. The department coordinates the Periodic Product Review program between multiple Genzyme sites and functions. The department provides expertise in statistical methodology, experimental design, process monitoring, and statistical training to support Science, Development and Operations.
Perform highly complex statistical data analysis on projects including multivariate data analysis, categorical data analysis, simulation, and time series data analysis.
Ensure all statistical methods comply with regulations, guidances and standards published by FDA, ICH, EMA and other regulatory groups in project area.
Collaborate in the design, development, and implementation of new SOPs, processes and statistical methodologies, and provide training to cross functional teams.
Review and sign-off on SOPs, protocols and reports.
Develop statistical programming and manage projects to meet deliverables and milestones.
Design experiments for assay development, troubleshoot, research and process capability independently.
Represent organization as the primary statistical contact on projects.
Provide guidance to less experienced staff as needed.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.