Manager – Oncology RWE Statistical Programming
Company: Amgen
Location: Hyderabad, Telangana, India
Job Type: Full-Time | On-Site
Experience: 6+ Years (Statistical Programming / Clinical Data)
Qualification: Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics, or related field
Approx Salary: ₹30 LPA – ₹50 LPA
Job Overview
Amgen is hiring a Manager – Oncology Real-World Evidence (RWE) Statistical Programming to lead statistical programming activities within the Center for Observational Research (CfOR).
This role involves managing a team of statistical programmers responsible for generating real-world evidence from healthcare data to support drug development, regulatory submissions, and commercialization strategies. The position requires both hands-on programming expertise and leadership capabilities to guide teams and deliver high-quality analytical outputs.
Key Responsibilities
1. Statistical Programming & Data Analysis
Write, test, and validate programs to generate analysis datasets and reports for regulatory submissions and publications.
Work with large real-world healthcare databases such as claims and electronic health records (EHR).
Develop and maintain macros, utilities, and statistical analysis tools.
2. Real-World Evidence (RWE) Development
Generate real-world evidence supporting drug development and commercialization decisions.
Partner with epidemiologists and research teams to explore healthcare data and disease trends.
Analyze data related to disease prevalence, treatment outcomes, safety, and healthcare utilization.
3. Project & Team Management
Lead and mentor senior statistical programmers and junior team members.
Track programming projects, manage timelines, and resolve technical issues.
Participate in recruitment, team performance management, and resource allocation.
4. Cross-Functional Collaboration
Work with biostatistics, epidemiology, clinical development, and regulatory teams.
Participate in multidisciplinary project meetings and represent the programming function.
Review study-related documents such as Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), and Data Management Plans.
5. Quality, Compliance & Documentation
Ensure programming activities comply with SOPs, regulatory standards, and departmental guidelines.
Participate in internal and external audits and respond to quality findings.
Contribute to the development of policies, SOPs, and best practices.
Required Skills
Technical Skills
Strong programming expertise in SAS or R
Advanced knowledge of SQL programming
Experience with real-world healthcare data (RWD) and clinical datasets
Familiarity with Unix environments and statistical programming workflows
Knowledge of clinical trial data standards such as CDISC (SDTM, ADaM)
Soft Skills
Leadership and team management
Strong analytical and problem-solving skills
Excellent communication and documentation abilities
Ability to work with globally distributed teams
Preferred Qualifications
Master’s Degree in Statistics, Computer Science, or related discipline
Experience with OMOP Common Data Model
Programming experience with Python
Experience working with healthcare databases such as MarketScan, Optum, Medicare, Flatiron, or CPRD
Key Competencies
Real-World Evidence (RWE) generation
Statistical programming for clinical trials and observational research
Agile project management
Epidemiology concepts such as incidence and prevalence analysis
Innovation, leadership, and collaboration
About the Company
Amgen is one of the world’s leading biotechnology companies, pioneering innovative medicines since 1980. The company focuses on addressing serious diseases with high unmet medical needs through advanced research in human biology, genetics, and biotechnology.
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