Manager, CSAR - SAS Edit Check Programmer

• The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical Reporting and will focus on supporting SAS Edit check programming activities.
• This role involves creating and implementing edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming.
• 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 of electronic data capture technology.
• The position will be responsible for quality and deliverables at the study and portfolio level.
• The Manager, CSAR - SAS Edit Check 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 technologies.
• Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.
• Coordinating and providing programming support to Clinical Study Teams.
• 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/programming complex SAS edit checks according to specifications, testing them for functionality, and identifying potential issues before implementation.
• 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.
• Strong understanding and experience in the use of performance management techniques, measures, problem-solving, and analytical thinking.
• Drug development and clinical trials processes.
• Data management processes.
• Programming of clinical trial databases and applications.
• Proficient in SAS edit check programming.
• Systems development lifecycle.
• Programming Languages.
• Project planning and management.
• Collaborating with global cross-functional teams (team/matrix environment).
• Quality management and Risk Analysis.
• Regulatory filings and inspections.
• Process improvement methodologies.

Basic Qualifications:

• Bachelor's degree or equivalent in life science, computer science, business administration, or a related discipline with 9-13 years of experience.
• Proven experience in managing teams.
• Specialist knowledge/experience in life sciences or a medically related field.
• General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company).

Preferred Qualifications:

• Advanced degree or equivalent in life science, computer science, math, statistics, business administration, or a related discipline with 9-13 years of experience.
• Broad knowledge/work experience in data management/programming in the Pharmaceutical or Biotech arena.
• Proven experience in managing teams.
• General project management and planning experience.
• Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, IRT vendors, etc.).