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Tier‑1 employer, metro Hyderabad location, and a mid-level (3–6yr) experience band increase competition.
Clinical biostatistics and CDISC regulatory expertise make background fit highly industry-specific.
Explicit 4+ years, mandatory SAS/CDISC skills and regulatory submission experience enforce strict screening.
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Perform hands-on statistical programming for clinical trial data analysis and regulatory submissions using SAS and/or R.
Create and validate complex SDTM, ADaM datasets, and statistical tables, listings, and figures for safety and efficacy.
Prepare statistical programming specifications and collaborate with global cross-functional teams, supporting or backing up the Study Lead Programmer.
Bachelor’s degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific fields.
At least 4 years of statistical programming experience in clinical development environment.
Proficient with SAS/STAT; working knowledge of CDISC SDTM standards; familiarity with ADaM and Define standards.
Excellent English communication skills; position located in Hyderabad at Amgen India.
Experienced in complex clinical data analysis and regulatory submission support.
Ability to manage multiple projects across therapeutic areas within global/dispersed teams.
Familiarity with open-source tools (R, Python) and knowledge in automation and emerging technologies is preferred.