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Manager, Biospecimen Reporting And Automation

Amgen
Amgen
5-10 years
₹30 LPA – ₹55 LPA
Hyderabad
10 March 16, 2026
Job Description
Job Type: Full Time Education: PhD/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 – Biospecimen Reporting and Automation

Company: Amgen
Location: Hyderabad, Telangana, India
Job Type: Full-Time | On-Site
Experience: 5 – 10+ Years (Clinical Data / Analytics / Automation in Life Sciences)
Qualification: Bachelor’s / Master’s / PhD in Life Sciences, Data Science, Bioinformatics, Statistics, or related field
Approx Salary: ₹30 LPA – ₹55 LPA


Job Overview

Amgen is seeking a Manager – Biospecimen Reporting and Automation to lead the development of automated reporting systems, dashboards, and analytics tools supporting biospecimen operations in clinical research.

The role focuses on data automation, analytics governance, and operational insights to improve reporting accuracy, reduce manual processes, and support decision-making across research and development teams.

The position collaborates closely with Clinical Operations, Data Management, IT, and Quality teams to ensure reliable analytics outputs that meet regulatory and operational standards.


Key Responsibilities

1. Reporting & Dashboard Development

  • Develop and maintain automated reports and dashboards for biospecimen operations.

  • Oversee regulated analytics deliverables such as Appendix I reports.

  • Review and approve dashboards, scripts, and reporting templates before production release.


2. Data Automation & Analytics

  • Build automated data pipelines using:

    • SQL queries

    • Python or similar scripting languages

  • Develop dashboards using BI tools such as Power BI or Tableau.

  • Improve data reliability and reduce manual reporting processes through automation.


3. Data Governance & Compliance

  • Ensure compliance with data governance standards, validation logic, and version control requirements.

  • Maintain documentation, validation evidence, and audit-ready reporting processes.

  • Manage automation change control lifecycle including development, testing, validation, and release.


4. Operational Analytics & KPI Reporting

  • Deliver monthly KPI dashboards and performance summaries for R&D leadership.

  • Generate study health reports, discrepancy trends, and operational insights.

  • Provide analytics supporting cross-therapeutic area performance reviews.


5. Cross-Functional Collaboration

  • Partner with Data Management, Clinical Operations, IT, and Quality teams.

  • Act as an escalation point for reporting issues, automation failures, and data discrepancies.

  • Drive continuous improvement initiatives to enhance data reporting capabilities.


Required Skills

Technical Skills

  • Advanced SQL querying and relational data modeling

  • Programming experience with Python or similar scripting language

  • Expertise with Business Intelligence tools such as Power BI or Tableau

Data & Analytics Skills

  • Strong understanding of data governance and validation frameworks

  • Experience building automated reporting pipelines and dashboards

  • Ability to translate operational processes into scalable data automation solutions


Preferred Qualifications

  • Experience working in biopharmaceutical R&D or clinical research environments

  • Experience managing CROs or external research vendors

  • Familiarity with regulated data environments and clinical trial reporting systems


Key Competencies

  • Data automation and reporting architecture

  • Advanced analytics and visualization

  • Clinical research data governance and compliance

  • Cross-functional collaboration in R&D operations

  • Continuous improvement and digital transformation


About the Company

Amgen is a global biotechnology leader dedicated to discovering and delivering innovative medicines for serious diseases. By integrating advanced biology, technology, and data science, Amgen continues to transform healthcare and improve patient outcomes worldwide.