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Biostatistical Programming Manager

2 months ago

Uxbridge, United Kingdom Amgen SA Full time
Biostatistical Programming Manager – Technical Manager

Key Responsibilities

In this critical role, you will oversee our Functional Services Provider (FSP) focusing on operational excellence and delivering projects on time to high quality and compliance levels. You will coordinate the implementation and quality of projects managed by FSP and ensure that projects are prioritized according to the product strategy.

  1. Responsible for projects managed by our FSP partners per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
  2. Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
  3. Align FSP assignments with Amgen Development priorities
  4. Responsible for FSP performance metrics development, data collection, and reporting and lead the GSP continuous improvement initiatives

Requirements

You will need to have a Bachelor's degree or equivalent in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject. You should also have extensive SAS programming and reporting experience including SAS Base, Macro, STAT, Graph, and SQL, among others. Additionally, you should have a detailed understanding of clinical trial processes in the biopharmaceutical industry, from data collection to analysis reporting.

  1. Ability to lead programmers in successful completion of all study programming activities and provide mentorship on technical and process-related questions
  2. Experience working in a globally dispersed team on Phase 1-4 clinical trials
  3. Experience creating SDTM and ADaM data sets, Tables, Figures and Listings
  4. Ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM and define standards
  5. Familiarity with other programming languages such as R and Python
  6. In-depth knowledge of SAS/Graph and STAT
  7. Regulatory submission experience
  8. Vendor and resource management experience
  9. Detailed understanding of data compliance checks such as Pinnacle 21

What We Offer

As a Biostatistical Programming Manager at Amgen, you will have the opportunity to work in a diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act. You will also have access to a vast array of learning and development opportunities, as well as a generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Location

Ability to work flexibly from home with regular office work in Uxbridge next generation workspace. Candidates who do not live within a commutable distance have the opportunity to work fully remotely within the United Kingdom.