PHARMAFull-time
Biostatistical Programming Senior Associate
By Admin · Biostatistics & Statistical Programming
HYDERABAD (IN)ONSITEPOSTED: 8/19/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities & Statistical Programming
Perform hands-on statistical programming to manipulate, analyze, and report complex clinical trial data using SAS and R in support of global clinical studies and health authority regulatory submissions.
Author, develop, and validate CDISC-compliant datasets including Safety and Efficacy SDTM and ADaM data structures.
Program and validate complex Tables, Listings, and Figures (TLFs/TLGs) for Clinical Study Reports (CSRs) and integrated summary submissions (ISS/ISE).
Prepare detailed statistical programming specifications, define.xml packages, and validation documentation in line with regulatory expectations.
Study Leadership & Cross-Functional Collaboration
Collaborate with biostatisticians, data managers, and global study teams to develop data quality checks, identify data anomalies, and maintain audit readiness.
Assist Study Lead Programmers (SLP) with project planning, resource tracking, and deliverable oversight, serving as backup SLP for assigned trials.
Support regulatory filing packages (US FDA, EMA) ensuring adherence to global CDISC standards and internal standard operating procedures (SOPs).
REQUIRED VERIFIED SKILLS
SAS
Statistical Programming
CDISC SDTM
CDISC ADaM
Tables Listings Figures (TLFs)
Clinical Trial Data Analysis
Define-XML
SAS/STAT
Data Validation
Clinical Study Reports (CSR)
COMPENSATION & REWARDS
₹11.0L - 19.0L per annum
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
RECOMMENDED TRAINING
1/3
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