Biostatistics Sr Mgr NB50302039 South San Fransiciso, CA

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.Biostatistics Manager is Responsible for the following-Create statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis)-Review and approve randomization specifications-Create statistical analysis plans-Create templates for tables, listings and graphs-Review and approve dataset specifications-Review and approve key study-related documents produced by other functions (e.g. CRFs, Data Management Plans etc)-Write, test, validate and execute software programs to produce SDF datasets and tables, listings and graphs (statistical analysis outputs) for inclusion within CSRs, ISS / ISE, publications and other communications-Participate in the finalization of protocol deviations and analysis sets-Create statistical reports-Create statistical text for CSRs, clinical publications and other communications-Plan and execute statistical review and QC of CSRs, clinical publications and other communications-Plan and execute statistical review and QC of ISS/ISE-Oversee the work of outsourcing partners and vendors at the product level-Create Requests for Proposals (RFPs) from outsourcing vendors for statistical services-Contribute to decisions on selection of outsourcing partners and vendors-Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents-Participate in study and systems audits by Amgen CQA and external bodies, and respond to audit questions and findings-May manage and develop a small number of statistical staff-Participate in the recruitment of statistical staff-Provide input to and participate in intra-departmental and global Biostatistics meetings-Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field-Promote and communicate statistical awareness and the role of the Biostatistics department (internal/external; scientific/process)-Contribute to the continuous improvement of Global Biostatistics.Basic Qualifications:- 4-6 years Scientific career experience without a PhD - 0-4 years Scientific career experience with a PhDPreferred Qualifications:-Statistical Methodology and Applications within Drug Development-Drug Development Process & Operations-Use of Biostatistical Software within Drug Development-Statistical Analysis-Clinical Trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia-Drug Development (Pre-clinical Development, Clinical Development, Medical Affairs)-Project Planning and Management-Communication of statistical information (written and oral)-Development of policies and SOPs Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit: www.amgen.com Company: Amgen San Francisco LLC Location: South San Francisco, CA 94080 Job Category: Biotech/R&D/Science Reference Code: 50302039