Job Description

Career Category EngineeringThe Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization.The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management.The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).Responsibilities include, but are not limited to, the following:

• Support of clinical trial platform technologiesxe2x80x8b
• Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.xe2x80x8b
• Coordinating and providing programming support to Clinical Study Teams xe2x80x8b
• Works collaboratively with Clinical Data Management to meet study deliverables and timelines
• Acting as a technical point of contact for systems deliverables on defined programs
• Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios.
• Providing technical and business process input / expertise on new and emerging technologies
• Develop, review and implement policies, SOPs and associated documents
• Assist in preparing for and responding to audit findings (internal or external).

Knowledge

• Good Clinical Practice xe2x80x8b
• Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking.xe2x80x8b
• Drug development and clinical trials processesxe2x80x8b
• Data management processesxe2x80x8b
• Programming of clinical trial databases and applicationsxe2x80x8b
• Proficient in SAS programming and Spotfire data visualization software
• Systems development lifecyclexe2x80x8b
• Programming Languages xe2x80x8b
• Project planning and managementxe2x80x8b
• Collaborating with global cross-functional teams (team/matrix environment)
• Quality managementxe2x80x8b and Risk Analysis
• Regulatory filings and inspections
• Process improvement methodologies

Preferred Qualifications

• Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related disciplinexe2x80x8b
• Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arenaxe2x80x8b
• General project management and planning experience xe2x80x8b
• Experience in oversight of outside vendors (CROxe2x80x99s, central labs, imaging vendors, IRT vendors, etc.)

Basic Qualifications

• Bachelorxe2x80x99s degree or equivalent in life science, computer science, business administration or related discipline xe2x80x8bwith 9 to 13 yrs of experience.
• Specialist knowledge / experience in life sciences or a medically related fieldxe2x80x8b
• General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

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Amgen