3 Csar Operations Jobs

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.

As the Manager, CSAR - Global Library , you will report to the Senior Manager of Clinical System and Analytical Reporting and will focus on supporting Global Library activities. This role is a blend of leadership and individual contribution, where you will provide database design services to clinical study teams, maintain standard libraries, and ensure adherence to Data Element Standards (DES) . The ideal candidate will be a strong leader with proven ability to influence stakeholders, and will contribute to large system transformation projects while ensuring high-quality deliverables. Roles & Responsibilities Global Library Management: You will provide Global Library review at the study level, coordinating closely with the Lead Data Manager. You will maintain standard libraries and provide database design services to clinical study teams in alignment with company standards. This includes creating and maintaining standard CRFs and Edit Checks in CDMS (RAVE) or other related technology. 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 offer technical and business process input on new and emerging technologies, and act as a data scientist to bring awareness to patterns and analytical insights. Process & Quality Assurance: You will lead or coordinate the definition of studies in clinical trial databases and systems. You will also maintain standard business processes within Global Development Operations ( GDO ) to ensure compliance with regulatory bodies. This includes developing, reviewing, and implementing policies, SOPs , and associated documents, as well as assisting in preparing for and responding to audit findings. Project Management: You will help deliver large system transformation projects, with a focus on project management, partner engagement, and organizational change. Technical Skills & Knowledge Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC ). Strong understanding and experience with Good Clinical Practice , drug development, and clinical trials processes. Knowledge of CDISC and SDTM . Experience in programming of clinical trial databases and applications. Understanding of the systems development lifecycle, project planning, and management. Broad knowledge or work experience in data management/programming in the Pharmaceutical or Biotech arena. Experience in oversight of outside vendors ( CROs , central labs, etc.) is a plus. Qualifications A Master's degree, Bachelor's degree, or Diploma in life science, computer science, business administration, or a related field. An advanced degree is a plus. Soft Skills Leadership: A strong leader with a proven ability to influence partners and effectively manage teams. Problem-Solving: Strong understanding and experience in using performance management techniques and analytical thinking. Communication: Excellent verbal and written communication skills, with a focus on collaborating 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.

We are seeking a talented individual to join us as a Study Designer and Edit Check Programmer within the Clinical Systems and Analytical Reporting ( CSAR ) team. This role is a crucial blend of technical expertise and leadership, where you'll build and program studies in our clinical trial database while ensuring compliance with Amgen's standards and procedures. You will act as a strong leader, influencing stakeholders and collaborating with cross-functional teams to deliver high-quality, seamless deliverables related to electronic data capture technology. Roles & Responsibilities Study Design & Programming: You will build and program studies in the clinical trial database, adhering to Amgen's standards and best practices. A key part of this is the development of custom functions and edit checks . Technical Leadership: Serve as a technical point of contact for system deliverables on defined programs. You will provide technical and business process expertise on new and emerging technologies and act as a data scientist to support decision-making through analytical insights. Process & Quality Assurance: Ensure the efficient and consistent use of EDC systems in compliance with established procedures. You will also develop, review, and implement policies, SOPs , and other documentation to ensure all CSAR activities are consistent with regulatory and established processes. Collaboration: Partner effectively with other CSAR Operations and cross-functional staff to ensure seamless deliverables. You'll also assist in preparing for and responding to audit findings. Innovation: Identify, recommend, or implement system enhancements, new tools, or emerging technologies to decrease database development cycle times and foster a collaborative environment. Technical Skills & Knowledge Strong knowledge of Good Clinical Practice , drug development, and clinical trial processes. Experience in programming and working with clinical trial databases and applications . Expertise in edit check development and custom function programming . Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC ). Understanding of the systems development lifecycle and programming languages. Knowledge of project planning and management, quality management, and risk analysis. Broad knowledge or work experience in data management/programming in the pharmaceutical or biotech industry. Qualifications A Bachelor's degree or equivalent in life science, computer science, business administration, or a related discipline. An advanced degree is preferred. General biopharmaceutical clinical research experience. Experience in oversight of outside vendors ( CROs , central labs, etc.) is a plus. Soft Skills Leadership: A strong leader with proven experience in influencing stakeholders and mentoring junior team members. Problem-Solving: Strong analytical and problem-solving skills, with experience in performance management techniques and measures. Communication: Excellent communication and collaboration skills, with the ability to work 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.