Amgen
Biotechnology
SeniorManager,BiostatisticalProgramming
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager, Biostatistical Programming at Amgen. Skills: Biostatistical programming, Team leadership, Regulatory submissions. Ensure execution of programming activities. Ensure successful execution of deliverables”
What You'll Achieve.
Successful execution and delivery; Timely completion of activities
Industry & Context.
What They're Looking For.
Must Have
8 years statistical programming experience, Technical skills, Communication skills, Leadership skills, Lead and manage programmers, Develop offshore programming team, Work across different time-zones, Advanced SAS analysis and reporting, Prior regulatory submission experience, Experience with data quality and compliance, Experience in software development, Work effectively in globally dispersed team, Prior staff development leadership, Project management experience, Excellent oral and written English, Perform complex statistical programming
Nice to Have
MSc or higher degree, Familiarity with R, Familiarity with Python, Familiarity with automation platforms, Familiarity with emerging technologies
What You'll Do.
Ensure execution of programming activities
Ensure successful execution of deliverables
Ensure successful implementation of strategies
Plan and monitor project progress
Address project issues
Provide input to resource plans
Monitor and utilize assigned staff
Lead process improvement initiatives
Participate in process improvement initiatives
Participate in cross-functional working groups
Assist in study audits
Assist in system audits
Develop controlled documents
Review controlled documents
Implement controlled documents
Provide hands-on support
Provide input into career development
How You'll Work.
Team & Collaboration
Cross-functional working groups; Globally dispersed team
Communication Scope
Oral communication; Written communication
Process & Methodology
Project management
Full Job Description
## **Career Category** Research ## ## **Job Description** **Senior Manager, Biostatistical Programming** **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. **Senior Manager, Biostatistical Programming** **What you will do** Let’s do this. Let’s change the world. Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Senior Manager of Biostatistical Programming (Programming Execution Lead), you will partner with the Global Programming Lead (GPL) and lead an offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. Together with the GPL, this Senior Manager will be accountable and responsible for Global Statistical Programming study results and drug approval submission activities for the assigned product areas. **Key Responsibilities:** * Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team. * Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally. * Plan and monitor progress of projects and address issues accordingly. * Provide GSP product level input to developing and managing resource plans a
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