Amgen
Biotechnology
BiostatisticalProgrammingSeniorAssociate
Neural analysis suggests this role is
optimal for Senior candidates.
“Biostatistical Programming Senior Associate at Amgen. Skills: Statistical programming, Clinical trial data, SAS, CDISC standards. Perform statistical programming activities. Support statistical data analysis”
Industry & Context.
What They're Looking For.
Must Have
4 years statistical programming experience, Familiarity with drug development life cycle, Ability to perform complex statistical programming, Ability to provide quality output, Ability to work on multiple tasks, Ability to work in globally dispersed team, Working knowledge of CDISC SDTM standards, Familiar with CDISC ADaM standards, Familiar with Define standards, In depth knowledge of SAS/STAT packages, Familiar with data quality tools, Familiar with compliance check tools, Excellent oral and written English skills
Nice to Have
MSc or higher degree, Familiarity with R, Familiarity with Python, Familiarity with automation platforms, Familiarity with emerging technologies, Prior regulatory submission experience
What You'll Do.
Perform statistical programming activities
Support statistical data analysis
Analyze clinical trial data
Report clinical trial data
Validate SDTM datasets
Validate ADaM datasets
Create safety datasets
Validate safety datasets
Create efficacy datasets
Validate efficacy datasets
Prepare statistical programming specifications
Prepare statistical programming documents
Maintain tracking documentation
Maintain validation documentation
Validate programs for checking data quality
Interact with study team members
Collaborate with cross-functional teams
Assist Study Lead Programmer
Serve as backup Study Lead Programmer
How You'll Work.
Team & Collaboration
Cross-functional teams; Globally dispersed team; Cross-cultural partners; Study team members
Communication Scope
Oral English; Written English
Full Job Description
## **Career Category** Clinical ## ## **Job Description** **Biostatistical Programming Senior Associate** **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 Senior Associate** **What you will do** Let’s do this. Let’s change the world. Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Senior Associate, you will perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions. **Key Responsibilities:** * Analysis and reporting of clinical trial data using SAS and/or R * Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy * Creation and validation of complex tables, listings, and figures, both safety and efficacy * Prepare statistical programming specifications * Prepare statistical programming related documents for regulatory submissions * Maintain tracking and validation documentation * Collaborate with cross-functional team and create and/or validate complex programs for checking data quality * Interact and collaborate with study team members from other functions globally * Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP This position will be located at Amgen India (Hyderabad). **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a re
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