Biostatistics Sr Manager - Nb50240061 - Thousand Oaks, Ca
Amgen USA (Ventura County, California)

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Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. Serve as a lead statistician in Global Safety and Independent Biostatistics. Lead life-cycle safety-related activities at the product level for multiple products. Provide strategic input and be the key safety biostatistics contact for regulatory safety queries and interactions with regulatory agencies. Support Risk Management Plan activities. Provide statistical support for independent Data Review Teams in monitoring safety and protecting trial integrity -Contribute to the design, conduct, and analysis of safety studies as well as exploratory analyses of existing databases in support of the understanding of the safety of Amgen products -Create statistical text for design documents and create analysis plans. Create templates for tables, listings, and graphs. Review dataset specifications. -Create statistical text for reports, clinical publications and other communications -Implement standard and consistent approaches in statistical practice for safety monitoring in trials and safety assessments to product quality information -Promote understanding of statistical methodologies with particular applicability to safety -Address statistical aspects of safety issues arising from clinical trials or spontaneous reporting of adverse experiences -Contribute to the development of signal detection capabilities for use in the analysis of pre-marketing and post-marketing adverse event databases -Contribute to the quantitative analysis of product benefit-risk profiles -Contribute to the enhancement of the infrastructure to allow easy and quality access to Amgen study databases and key external databases -Stay abreast of latest developments in the field of statistics in safety and contribute to advances in the field -Maintain close working relationships with biostatistics and programming leads -Create Requests for Proposals (RFPs) from outsourcing vendors for statistical services -Oversee the work of outsourcing partners and vendors for statistical services - May manage and develop a small number of statistical staff - Participate in the recruitment of statistical staff -Participate in the development and review of Amgen Policies, SOPs and other controlled documents -Contribute to continuous process development of Global Biostatistics and Epidemiology and Global Safety -Participate in study and systems audits by Amgen CQA and external bodies, and respond to audit questions and findings -Provide input to and participate in Global Biostatistics and Epidemiology meetings and Global Safety meetings - 4 years relevant career experience with a PhD - 6 years relevant career experience without a PhD - Familiarity with statistical methodology and applications within drug development or in a similar setting - Familiarity with drug development process & operations - Experience with use of relevant statistical software such as SAS or S+ Preferred Qualifications: - Project planning and management skills - Clear and concise written and verbal communication skills - Ability to help with the development of departmental policies, SOPs, and other controlled documents