Senior Associate – RWE Regulatory Statistical Programming – Amgen (Hyderabad)
Amgen is hiring a Senior Associate – RWE Regulatory Statistical Programming in Hyderabad, India to support its Center for Observational Research (CfOR) team. This role focuses on generating Real-World Evidence (RWE) and statistical analysis for regulatory submissions and drug development programs. The position involves working with large real-world healthcare datasets such as insurance claims, electronic health records (EHR), and patient registries to support research on disease patterns, treatment outcomes, and healthcare utilization. You will collaborate with epidemiologists, clinical research teams, and data scientists to analyze biomedical data and deliver high-quality statistical outputs for regulatory agencies, scientific publications, and internal research reports. This role is ideal for professionals with experience in statistical programming, real-world data analysis, clinical research analytics, and pharmaceutical data science. The estimated salary for this role ranges from ₹18 LPA to ₹28 LPA depending on experience in statistical programming, real-world evidence research, and clinical data analytics.
Key Responsibilities
Support statistical programming activities for regulatory submission studies and clinical research projects.
Write, test, and validate SAS, R, SQL, or Databricks programs to generate analysis datasets and statistical reports.
Analyze real-world healthcare data (RWD) such as insurance claims, EHR databases, and patient registries.
Collaborate with epidemiologists, data scientists, and research teams to generate real-world evidence for drug development.
Ensure accurate analysis and presentation of biomedical and clinical data.
Develop and review analysis dataset specifications, programming plans, and statistical outputs.
Participate in cross-functional project meetings and global research collaborations.
Lead process improvement initiatives and develop reusable programming macros and utilities.
Support clinical quality audits and regulatory compliance activities.
Required Qualifications
Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics, or related field.
4+ years of experience in statistical programming, clinical data analytics, or life sciences data analysis.
Strong experience with SAS or R programming and SQL.
Knowledge of clinical research data, drug development lifecycle, and epidemiology concepts.
Strong analytical, communication, and problem-solving skills.
Required Skills
Statistical Programming (SAS / R)
SQL Programming
Real-World Evidence (RWE) Analytics
Real-World Data (RWD) Analysis
Clinical Research Data Management
CDISC Standards (SDTM, ADaM)
Epidemiology & Biostatistics
Data Analysis & Reporting
Salary
Approximate Salary: ₹18,00,000 – ₹28,00,000 per year (depending on experience in statistical programming and real-world evidence analytics).
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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