Amgen Biostatistical Programming Senior Manager in Thousand Oaks, California

The Biostatistical Programming Senior Manager will define and execute department strategy for software tools and utilities, oversee the development and maintenance of departmental software utilities to support the analysis and reporting of clinical trial data for GSP, and lead a team of two direct reports and two dotted line reports.

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

Responsibilities:

*Maintain and develop re-usable software utilities for GBS and GSP

*Provide technical leadership and guidance for programming teams

*Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications

*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 deliverables with stakeholders

*Participate in the selection of appropriate technologies and software development tools based on GSP priorities and budget

*Serve as primary interface to stakeholders, other group leads, and senior management

*Make and ensure the implementation of high level strategic decisions

*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

*Coordinate and monitor project issue reporting and resolution

*Promote standard and consistent strategy and approaches to statistical programming

*Provide input in the development and review of GSP SOPs and other controlled documents

*Provide input into and help facilitate career development plans for all staff on assigned projects

Basic Qualifications:

Doctorate degree and 2 years Statistical Programming experience

OR

Master's degree and 6 years Statistical Programming experience

OR

Bachelor's degree and 8 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 or higher degree in quantitative, software engineering, or scientific subjects

8+ years of relevant statistical programming experience in a clinical development environment

*Familiarity with drug development life cycle and experience in analysis of clinical trials data

*Working knowledge of latest CDISC SDTM, ADaMand Define-XML standards

*Experience with object oriented software development using Java

*Experience working on both SAS and Java enterprise development projects

*Experience working with dynamic languages designed for the JVM, such as Groovy

*Experience with other statistical and data sciences programming languages (e.g. R, Python)

*Experience working with Oracle databases, including PL/SQL

*Working experience with external staffing providers

*Excellent oral and written English communication skills

*Good negotiation skills

*In-Depth experience developing re-usable software components using base SAS and SAS Macro

*Advanced experience in a Linux/UNIX environment including the automation of tasks using scripting

*Advanced experience in the software development life cycle

*Prior leadership and/or management experience

*Experience overseeing, prioritizing, and coordinating resources across multiple projects

*Ability to train others

*Thought leadership

*Application of lean software development principles

*In-depth knowledge of SAS Graph and Stat packages

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.

Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.