Senior Associate – RWE Regulatory Statistical Programming | Hyderabad, India
Location: Hyderabad, India
Job Type: Full-Time
Work Mode: On-site
Amgen is hiring a Senior Associate – RWE Regulatory Statistical Programming in Hyderabad, India to support statistical programming activities within the Center for Observational Research (CfOR). This role focuses on generating Real-World Evidence (RWE) for regulatory submissions and drug development by analyzing large real-world healthcare datasets. It is an excellent opportunity for professionals experienced in biostatistics, statistical programming, clinical research data, SQL, SAS/R, and healthcare analytics.
The Senior Associate will work closely with cross-functional global teams including epidemiologists, clinical researchers, and regulatory specialists to generate insights from real-world data (RWD) such as insurance claims, electronic health records (EHR), and patient registries. The role involves both hands-on programming and technical collaboration, ensuring that biomedical data analyses are accurate, compliant with regulatory standards, and delivered on time.
💰 Expected Salary (Approx.)
For Senior Associate / Senior Biostatistical Programmer roles in global pharmaceutical companies in India, the estimated salary range is:
₹18 LPA – ₹28 LPA (Estimated)
Compensation may vary based on:
Experience in clinical trial data analysis or real-world evidence research
Expertise in SAS, R, SQL, and statistical programming
Knowledge of regulatory standards such as CDISC (SDTM, ADaM)
Experience working with real-world healthcare databases
Educational qualifications such as Master’s degree in Statistics or Data Science
Global biotechnology companies like Amgen typically provide competitive compensation, performance bonuses, and strong career growth opportunities in clinical data science and pharmaceutical research.
Job Summary
The Senior Associate – RWE Regulatory Statistical Programming will support the statistical programming team responsible for conducting analyses for regulatory submission studies and real-world evidence projects. The role involves working with large healthcare datasets and generating analytical outputs used in regulatory filings, scientific publications, and internal research reports.
The position requires expertise in SAS or R programming and SQL, along with experience working with real-world healthcare data such as insurance claims databases, EHR systems, and patient registries. The candidate will collaborate with global teams to clarify analysis requirements, manage programming workflows, and ensure high-quality analytical results.
Key Responsibilities
Support the statistical programming team conducting analyses for regulatory submission studies
Develop and validate statistical programs using SAS, R, or Databricks
Analyze real-world healthcare data including insurance claims and EHR datasets
Generate analysis datasets, statistical outputs, and reports for regulatory submissions and scientific publications
Coordinate with functional leads to prioritize programming workflows
Ensure accuracy and completeness of biomedical data analysis
Write and review programming plans and dataset specifications
Participate in multidisciplinary project team meetings
Develop macros and utilities for statistical programming workflows
Follow Amgen policies, SOPs, and regulatory standards
Review key study documents such as Statistical Analysis Plans (SAPs) and Data Management Plans
Participate in clinical quality audits and regulatory reviews
Contribute to process improvement initiatives within CfOR
Required Skills & Qualifications
Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics, or related field
4+ years of experience in statistical programming or clinical data analysis
Strong experience in SAS or R programming
Strong proficiency in SQL
Experience working with real-world healthcare datasets
Understanding of clinical research data and statistical analysis workflows
Excellent communication, documentation, and collaboration skills
Ability to work effectively with global cross-functional teams
Preferred Skills
Master’s degree in Statistics, Computer Science, or Life Sciences
Experience with real-world evidence (RWE) generation
Knowledge of CDISC standards such as SDTM and ADaM
Experience working with healthcare databases such as MarketScan, Optum Clinformatics, Medicare, Flatiron, and CPRD
Familiarity with Python for healthcare data analysis
Understanding of drug development lifecycle and epidemiology concepts
Experience with Databricks or advanced data analytics platforms
Benefits & Career Opportunities
Opportunity to work with a global biotechnology leader
Exposure to real-world evidence research and regulatory data analytics
Work with global teams in clinical research and pharmaceutical R&D
Career growth in biostatistics, statistical programming, and healthcare data science
Opportunity to contribute to evidence generation supporting innovative therapies
About the Company
Amgen is a global biotechnology company focused on discovering, developing, and delivering innovative therapies for serious illnesses. Since its founding in 1980, the company has pioneered the use of human genetics and advanced biological research to create medicines that improve patient outcomes worldwide.
Amgen focuses on addressing diseases with high unmet medical needs, including oncology, cardiovascular diseases, inflammation, and rare conditions. Through its global research and development network, the company continues to develop breakthrough treatments that improve and extend patients’ lives.
How to Apply
If you have experience in statistical programming, clinical research data analysis, or real-world healthcare analytics, this role offers an opportunity to contribute to regulatory research and evidence generation for innovative medicines.
Apply now to join Amgen’s Center for Observational Research (CfOR) and help advance real-world evidence that supports life-changing therapies for patients worldwide.
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