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Location: San Diego, CA
Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and were always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.
Responsibilities
• Lead the statistical methodology research activity and provide statistical consultation to team members.
• Provide statistical input to clinical development projects to influence development strategies.
• Lead and interact with multiple functional teams to deliver results for specific projects.
• Support safety data analyses.
• Lead the statistical methodology research in Statistics group; provide statistical advice to other team members, as well as colleagues in other functional areas as needed.
• Keep up with the latest statistical methodology development by reviewing various statistical journals and regulatory guidelines. Lead the departmental seminar discussion and professional education.
• Identify and provide solutions to statistical issues related to clinical development projects, clinical research projects, and/or individual studies. Provide statistical input to clinical development projects to influence development strategies in multiple therapeutic areas
• Gain a good understanding of the designated therapeutic areas
• Participate in meetings with regulatory agencies
• Prepare/review submission documents to regulatory agencies
• Provide input to clinical study designs
• Review study protocols, write statistical sections, and perform sample size calculations
• Write/review statistical analysis plans, including the development of mock tables, figures and listings
• Take a leading role in organizing and participating in data review and results review meetings
• Write/review statistical sections of study reports
• Provide support to ad hoc/post hoc data analyses
• Provide support to manuscript preparation
• Interact with other functional groups to manage inter-departmental activities
• Interact and manage activities outsourced to contract research organizations
• Provide mentoring support to junior level statisticians
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