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Manager/Sr. Manager, Biostatistics
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA (R) (aflibercept) Injection, ZALTRAP (R) (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST (R) (rilonacept) Injection for Subcutaneous Use. Regeneron has filed a regulatory application with the U.S. Food and Drug Administration (FDA) for a second indication for EYLEA. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
The Senior Manager/Manager, Biostatistics directs statistical support and provides statistical leadership for all areas of clinical development, and has responsibility for strategic and operational activities. Promote development of key staff responsible for individual projects or areas. Implement and maintain policy for recruitment of high potential staff. Assisting VP, BDM, in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure. Responsible for project staffing and for appropriate resource allocation consistent with corporate priorities. Incumbent could serve as senior research expert, with demonstrated ability to be leader within CD&RA and within field for specific statistical methodology or application.
-Ph.D.in Statistics or related discipline and at least 5-10 years of related experience in the biotechnology, pharmaceutical or health related industry
-Significant interaction with both FDA and EMEA, history of successful project and people management, and expertise in multiple therapeutic areas
-Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks
-Works independently-self-directed, high energy and strong work ethic
-High degree of creativity, latitude and attention to detail required
-Demonstrated strong leadership, project management, teamwork, and interpersonal skills
-Excellent communication and presentation skills
-Experience and proven ability leading and managing major process and technology initiatives with utilization and impact across multiple functional groups
-Broad knowledge and superior understanding of advanced statistical concepts and techniques
-Outstanding ability and skills to effectively represent Biostatistics and Data Management in interaction with senior management or cross-functional committees
-Thorough knowledge of pharmaceutical clinical development and life cycle management
-Ability to innovatively apply technical principles, theories and concepts to clinical drug development leading to regulatory approvals
-Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice
-Understanding of the drug discovery and development process, regionally and globally
-Technical skills: SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
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