Senior Biostatistical Programming Manager

Amgen

Senior Manager developing and maintaining software utilities for clinical trial data analysis at Amgen. Providing technical leadership and overseeing programming teams for operational success.

Posted 5/20/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $157,896 - $213,625 per yearWebsite

Tech Stack

Tools & technologies

CloudETLJavaJavaScriptPerlPythonSDLCSQL

About the role

Key responsibilities & impact

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
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 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

Requirements

What you’ll need

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
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

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Statistical ProgrammingSASRPythonPerlJavaJavascriptSQLmachine learningETL

Soft Skills

technical leadershipguidancecollaborationmentorshipproject managementcommunicationresource managementoperational successcareer developmentstrategic decision making