Amgen Biostatistical Programming Manager in Cambridge, Massachusetts
The Biostatistical Programming Manager will provide technical expertise and programming leadership to ensure that software tools and utilities are properly developed and maintained to support the analysis and reporting of clinical trial data for GSP.
We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules. We are seeking top talent to ensure these molecules become medicines and realize their potential for helping patients.
Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data
Adhere to functional standards, processes and methods across all projects
Create, maintain, and review key SDLC documents - Requirements, Operational Qualification, Installation Qualification, and Design documents
Create, maintain, and review end-user documentation (e.g., user guides, training materials)
Participate in establishing the programming scope, timeline and quality for a deliverable with stakeholders
Participate in the selection of appropriate technologies and software development tools
Designated team leader responsible for project efficiency, timeliness and quality
Manage resource according to priorities. Match programmer abilities to tasks. Efficiently and effectively monitor and utilize assigned staff
Provide technical leadership and guidance for programming team
Lead all programming-related activities on one or multiple concurrent projects
Master’s degree and 3 years Statistical Programming experience
Bachelor’s degree and 5 years Statistical Programming experience
Associate’s degree and 10 years Statistical Programming experience
High school diploma and 12 years Statistical Programming experience
MSc degree in quantitative, software engineering, or scientific subjects
Familiarity with drug development life cycle and experience in analysis of clinical trials data
Working knowledge of latest CDISC SDTM, ADaM and Define-XML standards
Experience implementing test driven design strategies
In-depth knowledge of SAS Graph and Stat packages
Experience with programming languages (R, Python, or Perl)
Experience working with Oracle databases, including PL/SQL
Ability to train others
Prior leadership and/or management experience
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Get a fair share in success. Everyone’s contribution is recognized – and strong performance is rewarded.