Amgen
Biotechnology
AssociateDirector,BiostatisticalProgramming
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“Associate Director, Biostatistical Programming at Amgen. Skills: Biostatistical Programming, Clinical development, Regulatory submissions. Ensure successful execution analysis deliverables. Ensure successful execution regulatory submission packages”
What You'll Achieve.
Successful execution analysis deliverables; Successful execution submission packages; Improve quality; Improve efficiency
Industry & Context.
What They're Looking For.
Must Have
BASc or higher degree, 16 years of statistical programming experience, Technical skills, Communication skills, Leadership skills, Lead and manage large team, Develop successful offshore team, Work across different time-zones, Advanced SAS analysis and reporting, Advanced R analysis and reporting, Prior regulatory submission experience, Thorough understanding data quality, Experience working globally dispersed team, Prior staff development leadership, Project management experience, Excellent oral English skills, Excellent written English skills, Perform complex statistical programming
Nice to Have
MSc or higher degree, Familiarity with open-source tools, Familiarity with automation platforms, Familiarity with emerging technologies
What You'll Do.
Ensure successful execution analysis deliverables
Ensure successful execution regulatory submission packages
Implement programming strategies
Plan project progress
Monitor project progress
Address project issues
Provide GSP product input
Develop resource plans
Manage resource plans
Monitor assigned staff
Utilize assigned staff
Drive piloting new technologies
Integrate new technologies
Improve functional maturity
Lead departmental initiatives
Participate in departmental initiatives
Lead cross-functional groups
Participate in cross-functional groups
Represent GSP in audits
Represent GSP in inspections
Develop controlled documents
Review controlled documents
Implement controlled documents
Provide hands-on support
Provide coaching staff
Provide mentoring staff
Provide input career development
How You'll Work.
Team & Collaboration
Global Statistical Programming; Cross functional consultancy; Submission Consultancy Group; ADaM Consultancy Group; Cross-functional working groups
Communication Scope
Written communication; Oral communication
Process & Methodology
Project management
Full Job Description
## **Career Category** Clinical ## ## **Job Description** **Associate Director, 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. **Associate Director, 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 an Associate Director of Biostatistical Programming (Programming Execution Lead), you will partner with Global Programming Leads (GPL) and lead a large offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large, high priority products or indications across products. Together with GPL, this Associate Director will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned products or indications across products. The Associate Director of Biostatistical Programming will contribute at the department level by leading major GSP technical or operational efficiency initiatives and ensuring compliance with R&D standards, leading or serving as a member of GSP and cross functional consultancy groups such as Submission Consultancy Group and ADaM Consultancy Group. The Associate Director will drive the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-sou
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