Manager, CSAR – SAS Clinical Data Reporting and Spotfire Programmer
Location: Hyderabad, India
Work Location Type: On Site
Job ID: R-211029
Date Posted: April 17, 2025
Category: Engineering
About the Role:
Amgen is seeking a highly skilled professional to join as Manager, CSAR – SAS Clinical Data Reporting and Spotfire Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. This role focuses on creating patient data reports and dashboards while adhering to Amgen’s standards, procedures, and best practices. The successful candidate will leverage SAS programming and Spotfire visualization tools to deliver critical clinical trial insights.
The individual will collaborate with CSAR Operations and cross-functional teams to ensure the delivery of high-quality clinical systems outputs and activities related to electronic data capture (EDC) technology. The position carries responsibility for both study and portfolio-level deliverables and will contribute to large-scale system transformation projects, emphasizing project management, stakeholder engagement, subject matter expertise, and change management.
Roles & Responsibilities:
Provide programming support for clinical trial platform technologies.
Act as a data scientist by identifying patterns and offering analytical insights to support decision-making.
Coordinate and deliver programming support to Clinical Study Teams.
Collaborate with Clinical Data Management teams to meet study timelines and deliverables.
Serve as a technical point of contact for system deliverables across assigned programs.
Design and develop complex Spotfire visualizations and dashboards, with the ability to recommend appropriate charts based on business needs.
Provide technical and business process expertise for new and emerging technologies.
Develop, review, and implement policies, SOPs, and associated documents.
Assist in audit preparations and responses (internal and external).
Required Knowledge and Skills:
Knowledge of Good Clinical Practice (GCP).
Strong experience with performance management techniques, problem-solving, and analytical thinking.
Deep understanding of drug development and clinical trials processes.
Expertise in data management processes.
Proficiency in SAS programming and Spotfire data visualization software.
Experience in programming clinical trial databases and applications.
Understanding of systems development lifecycle.
Strong project planning and management skills.
Ability to collaborate effectively within global cross-functional and matrixed teams.
Knowledge of quality management and risk analysis principles.
Familiarity with regulatory filings and inspections.
Exposure to process improvement methodologies.
Preferred Qualifications:
Advanced degree or equivalent in life sciences, computer science, mathematics, statistics, business administration, or a related discipline.
Broad work experience in data management/programming within the pharmaceutical or biotech industries.
General project management and planning experience.
Experience overseeing external vendors (e.g., CROs, central labs, imaging vendors, IRT vendors).
Basic Qualifications:
Bachelor’s degree or equivalent in life sciences, computer science, business administration, or a related discipline with 9 to 13 years of relevant experience.
Specialist knowledge or experience in life sciences or a medically related field.
General biopharmaceutical clinical research experience gained while working on clinical trials at a biotech, pharmaceutical, or CRO company.
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