Biostatistical Programming Manager

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

- Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications - Efficiently manage project team resources and timelines - Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, NONMEM specifications, etc. - Write, and/or review and approve programming plans - Write, and/or review and approve analysis dataset specifications - Lead a complicated study, or lead multiple studies, with minimum supervision. - Represent the programming function and participate in multidisciplinary team meetings - Contribute to the continuous improvement of programming, Global Biomedical Data Sciences (GBS), and Research and Development (R&D) - Write, test and validate department-, product- and protocol-level macros and utilities - Participate in the development and review of GBS Policies, SOPs and other controlled documents - Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings - Interview potential programming candidates - Actively participate in external professional organizations, conferences and/or meetings - Provide input to and participate in intra-departmental and GBS meetings - Support and mentor junior programmers

- Bachelors or Masters degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject - For therapeutic area support, six (6) years clinical research and development programming experience - For system and process support, six (6) years project management and software application development experience - Drug Development (pre-, early, late and/or observational) in related industries or academic research - Project planning - Process improvement participation - International co-operation - Team participation and effectiveness - Advanced CDISC knowledge and implementation experience Knowledge - Computer programming, preferably SAS or other procedural languages - Understanding of computer operating systems, UNIX preferred - Biostatistical Programming within Drug Development - Drug Development Process & Operations Key Competencies - Scientific / Technical Excellence - Project Management - Team Work - Problem Solving - Attention to Detail - Oral and Written Communication