Biostatistical Programming Senior Manager – Real-World Evidence (RWE)
Location: Hyderabad, India
Work Mode: On-site
Job ID: R-235695
Category: Research & Real-World Evidence
Posted On: February 4, 2026
About the Role
The Biostatistical Programming Senior Manager – Real-World Evidence (RWE) plays a critical leadership role within the Centre for Observational Research (CfOR). This position is responsible for leading global biostatistical programming teams and collaborating closely with epidemiologists, RWE scientists, and programming leaders across multiple time zones to deliver high-quality real-world evidence using large-scale healthcare data.
Reporting to the Director of Biostatistical Programming, this role focuses on technical excellence, people leadership, process optimization, and timely delivery of complex RWE projects that support regulatory submissions, scientific publications, and strategic decision-making across Research & Development.
Key Responsibilities
Provide expert technical leadership and solutions for complex statistical programming challenges within CfOR.
Lead, mentor, and develop managers and statistical programmers to ensure consistent delivery of high-quality outputs.
Partner with epidemiologists and RWE leads to generate real-world evidence from large healthcare databases, including EHR and claims data.
Manage end-to-end programming activities, including resource planning, timeline tracking, risk mitigation, and issue resolution.
Ensure programming deliverables comply with departmental standards, SOPs, and regulatory expectations.
Author, review, and approve programming plans, analysis dataset specifications, and key study documentation.
Review and approve cross-functional documents such as Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), and Data Management Plans.
Develop, test, validate, and execute SAS- and SQL-based programs in Unix environments to produce analysis datasets and outputs for regulatory submissions and publications.
Design and maintain protocol-, product-, and department-level macros and utilities.
Oversee outsourced programming resources and ensure quality and timeline adherence.
Contribute to the development and maintenance of CfOR policies, SOPs, and controlled documents.
Support internal and external audits, including responses to Clinical Quality Assurance (CQA) findings.
Participate in recruitment, performance management, staff utilization, and professional development initiatives.
Represent the programming function in multidisciplinary project teams, internal forums, and external professional organizations.
Drive continuous improvement initiatives across programming, CfOR, and R&D functions.
Required Qualifications & Experience
Doctorate in Computer Science, Statistics, Mathematics, Life Sciences, Economics, or related discipline with 2+ years of relevant experience, OR
Master’s degree with 8–10 years of relevant experience, OR
Bachelor’s degree with 10–14 years of relevant experience, OR
Diploma with 14–18 years of relevant experience.
Preferred Experience
Minimum 8 years of hands-on statistical programming experience in life sciences, clinical development, or real-world evidence generation.
Demonstrated leadership or people-management experience within a statistical programming or RWE environment.
Experience leading statistical programming teams working with real-world healthcare data (RWD).
Exposure to RWE generation in pharmaceutical or related research industries, including clinical trials and observational studies.
Experience with the OMOP Common Data Model.
Strong background in global collaboration and cross-functional stakeholder engagement.
Technical Skills
Required:
SAS
SQL
Preferred:
R
Python
Strong experience with real-world healthcare data sources such as MarketScan, Optum Clinformatics, Medicare, Flatiron, CPRD, MDV, and EHR databases.
Knowledge of the drug development lifecycle and basic epidemiology concepts, including incidence and prevalence.
Core Competencies
Advanced statistical programming expertise
Leadership and team development
Agile project and resource management
Scientific and technical excellence
Clear written and verbal communication in English
Problem-solving and analytical thinking
Attention to detail and quality-driven mindset
Innovation, collaboration, and accountability
What Amgen Offers
Amgen is committed to supporting the professional growth, well-being, and career progression of its employees. The organization offers a collaborative global culture, learning opportunities, and competitive total rewards aligned with local market standards.
Join Amgen and contribute to generating impactful real-world evidence that improves patient outcomes worldwide.
Apply Now
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