Biostatistical Programming Manager
2 days ago
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
- 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
- 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
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.
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Uxbridge, United Kingdom Amgen Inc. (IR) Full timeBiostatistical Programming Manager – Technical ManagerAmgen is seeking a Biostatistical Programming Manager to join our Global Statistical Programming team. As a key member of our team, you will be responsible for ensuring that our FSP programming meets quality, compliance, timeline, and productivity expectations.Develop and implement quality metrics for...
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Uxbridge, United Kingdom Amgen Inc. (IR) Full timeJob SummaryWe are seeking a highly skilled Biostatistical Programming Manager to join our Global Statistical Programming team at Amgen Inc. (IR). As a key member of our team, you will be responsible for managing projects and ensuring that our programming meets quality, compliance, timeline, and productivity expectations.Key ResponsibilitiesManage projects...
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