Job Title: Manager – RWE Regulatory Statistical Programming
Location: Hyderabad, India
Work Mode: On-site
Company: Amgen
SEO URL Slug:
manager-rwe-regulatory-statistical-programming-hyderabad-amgen
Manager – RWE Regulatory Statistical Programming Job in Hyderabad | Amgen | SAS, R, SQL, Real World Evidence
Amgen is hiring a Manager – RWE Regulatory Statistical Programming in Hyderabad, India for its Center for Observational Research (CfOR) team. This pharmaceutical statistical programming leadership role focuses on generating Real-World Evidence (RWE) to support regulatory submissions, drug development, and healthcare decision-making.
The role involves leading statistical programming teams, analyzing real-world healthcare data, developing regulatory-ready datasets, and collaborating with global clinical research teams. Candidates with experience in SAS, R, SQL, CDISC standards (SDTM/ADaM), and real-world data sources such as MarketScan, Optum, and EHR datasets will be highly preferred.
This opportunity is ideal for professionals with strong expertise in clinical data analysis, epidemiology, regulatory statistical programming, and pharmaceutical RWE research who want to contribute to innovative biotechnology and drug development programs.
Approximate Salary Range: ₹30 LPA – ₹45 LPA (Estimated for Manager-level Statistical Programming roles in India)
Key Responsibilities
Lead and manage a statistical programming team supporting regulatory and observational research studies
Generate Real-World Evidence (RWE) for regulatory submissions, publications, and internal research projects
Write, test, and validate programs using SAS, R, SQL, and Databricks for clinical and observational data analysis
Develop analysis datasets, statistical outputs, and regulatory reports
Collaborate with epidemiologists, biostatisticians, and clinical research teams across global time zones
Manage project timelines, programming deliverables, and resource allocation
Ensure compliance with Amgen SOPs, regulatory standards, and data quality requirements
Review and approve study documentation including Statistical Analysis Plans (SAPs) and Data Management Plans
Develop reusable macros, utilities, and automated programming solutions
Participate in clinical quality audits and regulatory inspections
Lead technical initiatives to improve statistical programming processes and efficiency
Required Skills & Qualifications
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, Economics, or related fields
6+ years of experience in statistical programming within pharmaceutical or clinical research environments
Strong programming expertise in SAS, R, and SQL
Knowledge of CDISC standards (SDTM, ADaM) for clinical datasets
Experience working with Real-World Data (RWD) such as healthcare claims, EHR databases, and patient registries
Familiarity with datasets like MarketScan, Optum Clinformatics, Flatiron, Medicare, or CPRD
Understanding of drug development lifecycle, epidemiology, incidence/prevalence studies
Experience leading statistical programming teams or large clinical projects
Strong skills in data manipulation, clinical data analysis, and regulatory reporting
Excellent communication, documentation, and problem-solving abilities
Ability to work effectively in global, cross-functional pharmaceutical teams
Preferred Technical Skills
Python programming for advanced analytics
Experience with Databricks and large healthcare datasets
Agile project management in clinical data or biostatistics teams
Strong understanding of regulatory submission requirements
Perks & Benefits
Competitive pharmaceutical industry salary package
Opportunity to work with global biotechnology leaders
Exposure to Real-World Evidence (RWE) research and regulatory science
Career growth in biostatistics, clinical data science, and pharmaceutical analytics
Collaborative global work environment
Access to cutting-edge clinical research technologies and datasets
About Amgen
Amgen is one of the world’s leading biotechnology companies focused on discovering, developing, and delivering innovative medicines. With more than 40 years of leadership in biotechnology and drug development, Amgen leverages human genetics, advanced data science, and cutting-edge research to address serious diseases and improve patient outcomes globally.
Apply Now
If you have expertise in statistical programming, real-world evidence research, and clinical data analytics, this is an excellent opportunity to join a global pharmaceutical leader.
Apply now to advance your career in pharmaceutical biostatistics and regulatory data science.
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