Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer
Location: Hyderabad, India
Job ID: R-212019
Posted On: April 04, 2025
Work Type: On-Site | Full-Time
About Amgen:
Amgen is a pioneer in biotechnology, combining biology and data science to address the world’s toughest diseases. With over four decades of innovation, our therapies reach millions globally across Oncology, Inflammation, General Medicine, and Rare Diseases. Join us to improve lives while growing in a purpose-driven and collaborative work culture.
Position Summary:
As Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer, you will report to the Sr. Manager, Clinical System and Analytical Reporting. You’ll lead clinical data reporting and visualization activities using SAS and Spotfire, ensuring compliance with Amgen’s standards and timelines. The role demands strong technical proficiency, project leadership, cross-functional collaboration, and the ability to manage multiple priorities in a regulated, data-driven environment.
Key Responsibilities:
Clinical Data Reporting & Visualization:
Develop clinical trial dashboards and reports using SAS and Spotfire.
Support clinical study teams with data analytics and visual interpretation.
Act as the technical liaison for system deliverables across projects.
Provide expertise on performance metrics, visualizations, and reporting solutions.
Systems & Technology Operations:
Engage in clinical data platform integration, including EDC technologies (Rave, Veeva).
Troubleshoot, optimize, and support data flows for clinical platforms.
Contribute to transformation initiatives and system modernization projects.
Process & Quality Management:
Develop SOPs, policies, and documentation for data reporting standards.
Support regulatory filings and audit readiness through accurate data reporting.
Participate in internal/external audit responses and inspection preparedness.
Stakeholder Engagement & Leadership:
Collaborate with cross-functional stakeholders (CDM, Biostats, IT, QA).
Influence data decision-making with evidence-backed insights and visual reports.
Lead and mentor project-level team members in data reporting processes.
Required Qualifications:
Bachelor’s degree in life sciences, computer science, business administration, or related field with 6–8 years of relevant experience
OR
Master’s degree with 4–6 years of relevant experience
Preferred Qualifications:
Advanced degree in life sciences, statistics, or computer science
Strong hands-on experience with SAS programming and Spotfire dashboarding
Demonstrated project management and stakeholder engagement skills
Familiarity with EDC systems like Rave and Veeva
Understanding of GCP, regulatory requirements, and audit processes
Experience collaborating with vendors (e.g., CROs, IRT, imaging vendors)
Technical & Soft Skills:
Expert in clinical trial data reporting and visualization
Ability to convert raw data into compelling dashboards using Spotfire
Strong knowledge of clinical trial processes and drug development lifecycle
Excellent written and verbal communication
Ability to manage cross-functional teams and work in a global matrix environment
Strong problem-solving, risk management, and innovation mindset
Estimated Salary: ₹40–55 LPA (based on experience and market standards)
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