Amgen
biotechnology
SeniorManager,BiostatisticalProgramming
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“Senior Manager, Biostatistical Programming at Amgen. Skills: Biostatistical Programming, SAS, Leadership, Project Management. Ensure successful execution of end-to-end programming activities. Partner with Global Programming Lead”
What You'll Achieve.
Ensure successful execution and delivery of Global Statistical Programming milestone analysis deliverables; Ensure successful execution and delivery of regulatory submission packages; Successful and timely completion of all programming activities for a study or multiple studies from end to end
Industry & Context.
Address issues accordingly; Ability to effectively perform complex statistical programming and related tasks
Flexibility and desire to work across different time-zones
What They're Looking For.
Must Have
BASc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, 8 years of statistical programming experience in clinical development environment, technical, communication, and leadership skills, Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end, Experience developing a successful offshore statistical programming team, Flexibility and desire to work across different time-zones, Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, SQL), Prior regulatory submission experience for drug approval, Thorough understanding and experience with data quality and compliance checks, Experience in software development (e. g. , gathering user requirements, creating technical specifications, developing code, creating, and driving test plans), Experience working effectively in a globally dispersed team environment with cross-cultural partners, Prior staff development leadership and project management experience, Excellent oral and written English communication skills, Ability to effectively perform complex statistical programming and related tasks
Nice to Have
MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects, Familiarity with open-source programming tools (e. g. , R, Python), automation platforms, emerging technologies in statistical programming
What You'll Do.
Ensure successful execution of end-to-end programming activities
Partner with Global Programming Lead
Lead offshore team of Study Lead Programmers
Ensure successful execution and delivery of milestone analysis deliverables
Ensure successful implementation of programming strategies
Plan and monitor progress of projects
Address issues accordingly
Provide GSP product level input
Manage resource plans and budgets
Monitor and utilize assigned staff
Lead departmental process improvement initiatives
Participate in cross-functional working groups
Assist in study and system audits
and implement Policies
Provide hands-on support
Provide coaching and mentoring
Provide input into career development plans
How You'll Work.
Team & Collaboration
Partner with the Global Programming Lead (GPL); Work with GPL to ensure successful implementation of programming strategies; Work effectively in a globally dispersed team environment; Work with cross-cultural partners; Participate in cross-functional working groups
Communication Scope
technical, communication, and leadership skills; Excellent oral and written English communication skills
Process & Methodology
Plan and monitor progress of projects, Address issues accordingly, Project management experience
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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