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Manager, Csar - Sas Clinical Data Reporting And Spotfire Programmer

4-8 years
₹40–55 LPA
10 July 6, 2025
Job Description
Job Type: Full Time Education: BCS/B.com/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

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)