At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Biostatistical Programming Senior Manager
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will be responsible for the development and maintenance of departmental software utilities to support the analysis and reporting of clinical trial data for GSP.
Maintain and develop re-usable software utilities for GBS and GSP
Provide technical leadership and guidance for programming teams
Oversee FSP programming team. Provide guidance and support to ensure their operational success.
Partner with IS to maintain and enhance GSP systems and ensure that they are meeting the needs of statistical programming
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
Make and ensure the implementation of high level strategic decisions, including GSP strategy for adopting newer programming (R, Python, and other)
Designated team leader responsible for project efficiency, timeliness and quality
Manage resource according to priorities. Match programmer abilities to tasks. Efficiently and optimally monitor and utilize assigned staff
Provide technical leadership and guidance for programming team
Lead all programming-related activities on one or multiple concurrent projects
Leads and manages projects and accountable for all deliverables
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
Provide mentorship to staff
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is a strong analyst with these qualifications.
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
Solid understanding of the latest CDISC SDTM, ADaM, and Define-XML standards
Expertise with at least one of the following programming languages (SAS, R, Python) and preferably proficiency/expertise with a second programming language (SAS, R, Python, Perl, Java, Javascript, SQL)
Experience with advanced programming capabilities (machine learning, databricks, AI for application development/code generation)
Experience with systems and application programming architectures and platforms including cloud computing, automation, ETL, and other technologies
Excellent oral and written communication skills
Prior staff development leadership and project management experience
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.
