Manager, CSAR

4 weeks ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

As the Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer, you will report to the Senior Manager of Clinical System and Analytical Reporting. This role is focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. You will be responsible for creating patient data reports and dashboards, adhering to Amgen's standards and best practices. This position requires you to be a strong leader and an individual contributor, partnering with cross-functional teams to ensure high-quality deliverables and supporting large system transformation projects.

Roles & Responsibilities

- Data Reporting & Visualization: You will create patient data reports and dashboards using SAS for programming and Spotfire for visualization. This includes creating complex Spotfire visualizations and dashboards and justifying or suggesting charts based on business scenarios.
- Technical Leadership & Collaboration: You will act as a technical point of contact for systems deliverables and provide programming support to Clinical Study Teams. You will work collaboratively with Clinical Data Management to meet study deliverables and timelines. You will also act as a data scientist, using analytical insights to support decision-making.
- Process & Quality Assurance: You will provide technical and business process expertise on new and emerging technologies. You will also develop, review, and implement policies, SOPs, and associated documents, as well as assist in preparing for and responding to audit findings.
- Project Management: You will help deliver large system transformation projects, focusing on project management, partner engagement, and organizational change.

Technical Skills & Knowledge

- Proficient in SAS programming and Spotfire data visualization software.
- Strong understanding and experience with Good Clinical Practice, drug development, and clinical trials processes.
- Knowledge of data management processes and the programming of clinical trial databases and applications.
- Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).
- Experience with project planning and management, quality management, and risk analysis.
- Broad knowledge or work experience in data management/programming in the Pharmaceutical or Biotech industry.
- Experience in oversight of outside vendors (CROs, central labs, etc.) is a plus.

Qualifications

- A Bachelor's degree or equivalent in life science, computer science, business administration, or a related field, or a Master's degree.
- An advanced degree is a plus.
- General biopharmaceutical clinical research experience.

Soft Skills

- Leadership: A strong leader with a demonstrated ability to influence partners.
- Problem-Solving: Strong analytical and problem-solving skills, with experience in performance management techniques.
- Communication: Excellent verbal and written communication skills, with the ability to collaborate effectively with global, cross-functional teams.
- Proactiveness: High degree of initiative and self-motivation, with the ability to manage multiple priorities successfully.
- Teamwork: Team-oriented, with a focus on achieving team goals.

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