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Senior Associate - Rwe Regulatory Statistical Programming

Amgen
Amgen
4+ years
₹18 LPA – ₹28 LPA (Estimated)
Hyderabad
10 March 10, 2026
Job Description
Job Type: Full Time Education: BCS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.