Sanofi Group Senior Biostatistician in Westborough, Massachusetts
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.
Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law
JOB DESCRIPTION - Senior Biostatistician
Position will support drug Manufacture Operations and Development in statistical design and analysis.
Activities supported include: Method Validation and Transfer, Process Validation and Transfer, Process Capability, Expiration Dating, Process Monitoring, Training, Regulatory Submissions, Specification Development and Writing Statistical Practice Documents and Operating Procedures. Review and Approval of GMP Documents
Candidate should have an in-depth and broad understanding of a variety of statisticalmethodologies including:
Completing Statistical Programing and Simulations, Control Charting, Sample SizeCalculations, Design of Experiments,Distribution and Outlier Analysis, Transformations, Statistical Hypothesis Testing, Regressionand Anova, MultivariatAnalysis, Descriptive Statistics.
Statistical Software expertise
Candidate should be able to work independently within a highly regulated industry.
- Bachelor’s degree or equivalent and 7 years of experience OR Master’s degree instatistics/biostatistics/mathematics and 4 years of experience OR PhD instatistics/biostatistics OR PhD in related disciplines with M.S. in statistics/biostatistics and 2years of experience. #LI-GZ
In-depth and broad understanding of a variety of statistical methodologies to form technical solutions.
Demonstrated ability to guide the successful completion of projects and function in a project leadership role.
Statistical programing capability (SAS)
In-depth and broad understanding of a variety of statistical methodologies to form technical solutions.Demonstrated ability to guide the successful completion of projects and function in a project leadership role.Statistical programing capability (SAS)
Job: Clinical Development
Primary Location: United States-Massachusetts-Westborough
Job Posting: Jul 15, 2016, 9:38:28 AM
Job Type: Regular
Employee Status: Regular