Biostatistical Programming Senior Manager
Amgen
17 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Biostatistical Programming Senior Manager
What You Will Do
- Maintain and develop reusable software utilities for GBS and GSP
- Provide technical leadership and guidance for programming teams
- Oversee FSP programming team; guide and support operational success
- Partner with IS to maintain/enhance GSP systems to meet statistical programming needs
- Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications
- Develop and maintain departmental software utilities for clinical trial analysis and reporting
- Adhere to functional standards, processes, and methods across projects
- Create, maintain, and review SDLC documents (Requirements, Operational Qualification, Installation Qualification, Design)
- Create, maintain, and review end-user documentation (user guides, training materials)
- Establish programming scope, timeline, and quality with stakeholders
- Select appropriate technologies and software development tools based on priorities and budget
- Implement strategic decisions, including GSP strategy for adopting R, Python, and other newer programming
- Lead project efficiency, timeliness, and quality; manage resources and monitor/optimize staff utilization
- Lead all programming-related activities across one or multiple concurrent projects; manage projects and ensure deliverables
- Coordinate/monitor issue reporting and resolution; promote standard statistical programming approaches
- Provide input on GSP SOPs and other controlled documents; facilitate career development and provide mentorship
What We Expect Of You
Basic Qualifications:
- Doctorate + 2 years statistical programming OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school diploma + 12 years
Preferred Qualifications:
- MSc+ in quantitative, software engineering, or scientific subjects
- 8+ years in clinical statistical programming
- Drug development life cycle and clinical trial data analysis experience
- CDISC SDTM, ADaM, Define-XML knowledge
- SAS/R/Python expertise; preferably a second language (Perl, Java, Javascript, SQL)
- Advanced capabilities (machine learning, Databricks, AI)
- Cloud/automation/ETL and application architecture experience
- Excellent oral and written communication; staff development leadership and project management
Benefits (explicitly stated)
- Generous Total Rewards Plan (health, finance/wealth, work/life balance, and career benefits)
Application Instructions
- Apply at careers.amgen.com; no application deadline—applications continue until a sufficient number is received or a candidate is selected.
What You Will Do
- Maintain and develop reusable software utilities for GBS and GSP
- Provide technical leadership and guidance for programming teams
- Oversee FSP programming team; guide and support operational success
- Partner with IS to maintain/enhance GSP systems to meet statistical programming needs
- Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications
- Develop and maintain departmental software utilities for clinical trial analysis and reporting
- Adhere to functional standards, processes, and methods across projects
- Create, maintain, and review SDLC documents (Requirements, Operational Qualification, Installation Qualification, Design)
- Create, maintain, and review end-user documentation (user guides, training materials)
- Establish programming scope, timeline, and quality with stakeholders
- Select appropriate technologies and software development tools based on priorities and budget
- Implement strategic decisions, including GSP strategy for adopting R, Python, and other newer programming
- Lead project efficiency, timeliness, and quality; manage resources and monitor/optimize staff utilization
- Lead all programming-related activities across one or multiple concurrent projects; manage projects and ensure deliverables
- Coordinate/monitor issue reporting and resolution; promote standard statistical programming approaches
- Provide input on GSP SOPs and other controlled documents; facilitate career development and provide mentorship
What We Expect Of You
Basic Qualifications:
- Doctorate + 2 years statistical programming OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school diploma + 12 years
Preferred Qualifications:
- MSc+ in quantitative, software engineering, or scientific subjects
- 8+ years in clinical statistical programming
- Drug development life cycle and clinical trial data analysis experience
- CDISC SDTM, ADaM, Define-XML knowledge
- SAS/R/Python expertise; preferably a second language (Perl, Java, Javascript, SQL)
- Advanced capabilities (machine learning, Databricks, AI)
- Cloud/automation/ETL and application architecture experience
- Excellent oral and written communication; staff development leadership and project management
Benefits (explicitly stated)
- Generous Total Rewards Plan (health, finance/wealth, work/life balance, and career benefits)
Application Instructions
- Apply at careers.amgen.com; no application deadline—applications continue until a sufficient number is received or a candidate is selected.