Senior Associate – RWE Regulatory Statistical Programming
Company: Amgen
Location: Hyderabad, Telangana, India
Job Type: Full-Time | On-Site
Experience: 4+ Years (Statistical Programming / Clinical Data)
Qualification: Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics, or related field
Approx Salary: ₹18 LPA – ₹30 LPA
Job Overview
Amgen is hiring a Senior Associate – RWE Regulatory Statistical Programming to support statistical programming activities within the Center for Observational Research (CfOR).
The role focuses on generating Real-World Evidence (RWE) from healthcare data to support regulatory submissions, clinical development, and observational research. The position requires strong expertise in statistical programming, healthcare datasets, and regulatory data analysis while collaborating with global cross-functional teams.
Key Responsibilities
1. Statistical Programming & Data Analysis
Develop and validate programs using SAS, R, or Databricks to generate analysis datasets and reports.
Perform statistical programming to support regulatory submission studies and observational research projects.
Ensure the accuracy and completeness of biomedical data analysis and presentation.
2. Real-World Evidence (RWE) Generation
Work with real-world healthcare datasets such as claims databases and electronic health records (EHR).
Collaborate with epidemiologists and research teams to analyze healthcare data and disease trends.
Generate insights on disease burden, treatment outcomes, safety, and healthcare utilization.
3. Programming & Technical Support
Provide technical solutions to programming challenges within the CfOR team.
Develop macros, utilities, and reusable programming tools for analysis workflows.
Write and review programming plans and analysis dataset specifications.
4. Cross-Functional Collaboration
Participate in multidisciplinary project meetings and represent the programming function.
Coordinate with functional leads to prioritize programming tasks and project timelines.
Review key study documents such as Statistical Analysis Plans (SAPs) and Data Management Plans.
5. Compliance & Quality Assurance
Ensure programming activities follow Amgen policies, SOPs, and regulatory standards.
Participate in internal and external audits and respond to quality or compliance findings.
Contribute to process improvement initiatives and departmental best practices.
Required Skills
Technical Skills
Advanced statistical programming using SAS or R
Strong knowledge of SQL programming
Experience with clinical or observational healthcare datasets
Familiarity with CDISC standards (SDTM, ADaM)
Experience working in Unix or data analytics environments
Soft Skills
Strong analytical and problem-solving skills
Effective communication and documentation abilities
Ability to collaborate with global cross-functional teams
High attention to detail and quality standards
Preferred Qualifications
Master’s Degree in Statistics, Computer Science, or related field
Programming experience with Python
Experience working with real-world healthcare data (RWD) such as:
MarketScan
Optum Clinformatics
Medicare
Flatiron
CPRD
Key Competencies
Real-World Evidence (RWE) generation
Statistical programming for clinical trials and observational research
Epidemiology concepts such as incidence and prevalence analysis
Agile project management and global collaboration
Innovation, teamwork, and technical excellence
About the Company
Amgen is one of the world’s leading biotechnology companies, pioneering innovative therapies since 1980. The company focuses on developing medicines for serious diseases with high unmet medical needs, leveraging advanced research in genetics, biology, and biotechnology.
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