Amgen
biotechnology
BiostatisticalProgrammingSeniorAssociate
Neural analysis suggests this role is
optimal for Senior candidates.
“Biostatistical Programming Senior Associate at Amgen. Skills: SAS, R, SDTM, ADaM. Perform statistical programming activities. Support data analysis of clinical studies”
Industry & Context.
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 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment, Familiarity with drug development life cycle, excellent skills with the manipulation, analysis and reporting of complex clinical trial data, Ability to effectively perform complex statistical programming and related tasks, Ability to provide quality output and deliverables in adherence with challenging timelines, Ability to work effectively on multiple tasks or projects across therapeutic areas, Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners, Working knowledge of latest CDISC SDTM standards, familiar with CDISC ADaM and Define standards with ability to implement the standards, In depth knowledge of SAS/STAT packages, Familiar with data quality and compliance check tools, Excellent oral and written English communication skills
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, emerging technologies in statistical programming, Prior regulatory submission experience for drug approval
What You'll Do.
Perform statistical programming activities
Support data analysis of clinical studies
Support regulatory submissions
Analysis and reporting of clinical trial data
Creation and validation of SDTM
Creation and validation of ADaM
Creation and validation of analysis datasets
Creation and validation of tables
Creation and validation of listings
Creation and validation of figures
Prepare statistical programming specifications
Prepare statistical programming documents
Maintain tracking documentation
Maintain validation documentation
Create programs for checking data quality
Validate programs for checking data quality
Assist Study Lead Programmer
Serve as backup Study Lead Programmer
How You'll Work.
Team & Collaboration
Collaborate with cross-functional team; Interact and collaborate with study team members; work effectively in a globally dispersed team environment
Communication Scope
Excellent oral and written English communication skills
Full Job Description
## **Career Category** Research ## ## **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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