Amgen
biotechnology
BiostatisticalProgrammingManager
Neural analysis suggests this role is
optimal for Senior candidates.
“Biostatistical Programming Manager at Amgen. Skills: Biostatistical Programming, Statistical Programming, SAS, CDISC Standards (SDTM, ADaM), Team Leadership, Project Management. Serve as the Study Lead Programmer (SLP) for one or more studies. Lead a team of statistical programmers to support all statistical programming activities within a study”
What You'll Achieve.
Ensure timelines, quality, and compliance of all deliverables; Successful and timely completion of all programming related activities for a study end-to-end
Industry & Context.
Superior statistical programming and problem-solving skills within clinical development environment
What They're Looking For.
Must Have
BASc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, at least 6 years of statistical programming experience in clinical development environment, Thorough understanding of clinical trial processes, from data collection to analysis reporting, Proven record of superior statistical programming and problem-solving skills within clinical development environment, Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end, In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with ability to implement all aspects of those standards, Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others, Experience in data quality and compliance check tools, Excellent project management skills and ability to lead multiple projects effectively, Excellent oral and written English communication skills, Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners, Willingness and ability to provide guidance to team members on technical and process questions
Nice to Have
MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects, Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming, Prior regulatory submission experience for drug approval
What You'll Do.
Serve as the Study Lead Programmer (SLP) for one or more studies
Lead a team of statistical programmers to support all statistical programming activities within a study
Support regulatory submissions
Set the programming strategy for studies and projects
and compliance of all deliverables
Lead and manage specific programming tasks
Participate in establishing the programming scope for a deliverable
Participate in establishing detailed timelines
Create and maintain programming related specifications (e.g.
Represent GSP at the Clinical Study Team (CST)
Provide programming input into cross-functional study start-up activities
Perform hands-on statistical programming
Manage individual programmer work assignments
Provide technical leadership and guidance for study programming team
Coordinate and monitor data issue reporting and resolution
Coordinate with other SLPs to providing consistent deliverables across studies within a product
Manage technical aspects of project (e.g.
create/manage computing environment
Provide training and guidance to other programmers
Assume product level responsibilities as delegated by Global Programming Lead (GPL) and/or Programming Execution Lead (PEL)
How You'll Work.
Team & Collaboration
Represent GSP at the Clinical Study Team (CST); Attend meetings for, and provide programming input into, cross-functional study start-up activities; Initiate cross-functional team meetings as necessary; Coordinate with other SLPs to providing consistent deliverables across studies within a product; Provide training and guidance to other programmers; Work effectively and successfully in a globally dispersed team environment with cross-cultural partners
Communication Scope
Excellent oral and written English communication skills
Process & Methodology
Excellent project management skills, Ability to lead multiple projects effectively, Manage individual programmer work assignments to ensure timely, high-quality deliverables, Manage technical aspects of project (e.g., create/manage computing environment, lookup tables, etc.)
Full Job Description
## **Career Category** Research ## ## **Job Description** **Biostatistical Programming Manager** **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. **Biostatistical Programming Manager** **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 Biostatistical Programming Manager, you will serve as the Study Lead Programmer (SLP) for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study. You may also support regulatory submissions. **Key Responsibilities:** * Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer * Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables * Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team * Participate in establishing the programming scope for a deliverable with the statisticians and the study team * Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project * Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects * Represent GSP at the Clinical Study Team (CST) * Attend meetings for, and provide progra
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