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Tier-1 brand, metro location, and mid-level generalist experience amplify candidate competition.
Role requires domain-specific clinical trial, regulatory and CDISC expertise, limiting transferability across industries.
Mandatory CDISC/SAS/ADaM skills and minimum 4 years clinical statistical programming make filtering strict.
Perform hands-on statistical programming for complex clinical trial data analysis and regulatory submissions using SAS and/or R.
Create and validate complex SDTM, ADaM datasets and related tables, listings, and figures for safety and efficacy.
Prepare programming specifications, maintain validation documentation, and collaborate with global cross-functional teams; support or backup Study Lead Programmer tasks.
Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.
At least 4 years of statistical programming experience in a clinical development environment.
Working knowledge of CDISC SDTM standards and familiarity with CDISC ADaM and Define standards; strong SAS/STAT expertise.
Location requirement: position located in Amgen India (Hyderabad).
Experienced in complex clinical data programming and analysis with in-depth knowledge of CDISC standards and SAS/STAT packages.
Able to manage multiple projects effectively under challenging timelines within globally dispersed, cross-cultural teams.
Familiarity with regulatory submissions and open-source tools like R and Python is preferred but not mandatory.