Amgen Senior Associate Biostatistical Programming in Shanghai, China

The Senior Associate Statistical Programmer reports to Biostatistical Programming Lead in Amgen Asia R&D Center in Shanghai. This role serves as the regional biostatistics programming Therapeutic Area lead for cardiovascular disease, and is responsible for the biostatistical programming activities in covered products in internal pipeline & in related external collaboration. This role independently leads or manages multiple products/studies, ensures that all statistical programming aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy.

*Assist in the review of key study-related documents produced by other functions, e.g. case report form, data management plan

*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

*Understand and execute department-, product- and study-level macros and utilities

*Write, test and validate product- and study-level macros and utilities

*Assist with study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

*Provide input to and participate in intra-departmental and GBS meetings

*Contribute to the continuous improvement of Global Biostatistical Science (GBS) and programming

*Assist in the review of GBS policies, standard operating procedures and other controlled documents

*Provide support to and mentor more junior programmers

*Interface with outsourcing partners and vendors

*Attend external professional organizations, conferences, training and/or meetings

*Oversee FSP deliverables in compliant with company process and ensure quality