Biostatistics Manager
2 weeks 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 ensuring that our FSP programming meets quality, compliance, timeline, and productivity expectations.
Key Responsibilities:
- Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
- Responsible for FSP performance metrics development, data collection, and reporting
- Lead the GSP continuous improvement initiatives
You would be joining a diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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, among others
- Detailed understanding of clinical trial processes in the biopharmaceutical industry, from data collection to analysis reporting
- Ability to lead programmers in successful completion of all study programming activities and provide mentorship on technical and process related questions
- Experience creating SDTM and ADaM data sets, Tables, Figures and Listings
- 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
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. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Flexible work models, including remote work arrangements, where possible. Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.
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