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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.

Responsibilities:

  • 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

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years Statistical Programming experience

OR

Bachelor’s degree and 5 years Statistical Programming experience

OR

Associate’s degree and 10 years Statistical Programming experience

OR

High school diploma and 12 years Statistical Programming experience

Preferred Qualifications:

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.

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