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Biostatistical Programming Manager

2 months ago

Uxbridge, United Kingdom Amgen SA Full time
Job Title: Biostatistical Programming Manager

Amgen is seeking a highly skilled Biostatistical Programming Manager to join our Global Statistical Programming team. As a key member of our team, you will be responsible for overseeing the implementation and quality of projects managed by our Functional Services Provider (FSP) partners.

Key Responsibilities:
  • Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
  • Align FSP assignments with Amgen Development priorities
  • Responsible for FSP performance metrics development, data collection, and reporting
  • Lead the Global Statistical Programming continuous improvement initiatives
Requirements:
  • Bachelor's degree or equivalent in Computer Science, Statistics, Mathematics, Life Sciences, or other relevant scientific subject
  • Extensive SAS programming and reporting experience, including SAS Base, Macro, STAT, Graph, and SQL
  • Detailed understanding of clinical trial processes in the biopharmaceutical industry
  • Ability to lead programmers in successful completion of all study programming activities and provide mentorship on technical and process-related questions
  • Experience working in a globally dispersed team on Phase 1-4 clinical trials
  • Experience creating SDTM and ADaM data sets, Tables, Figures, and Listings
  • Ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM, and define standards
  • Familiarity with other programming languages such as R and Python
  • In-depth knowledge of SAS/Graph and STAT
  • Regulatory submission experience
  • Vendor and resource management experience
  • Detailed understanding of data compliance checks such as Pinnacle 21
What We Offer:
  • 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
  • Flexible work models, including remote work arrangements, where possible
Equal Opportunity Statement:

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