Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer

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 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
• 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 programming and Spotfire data visualization software
• 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

Preferred Qualifications

Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline with 9-13 years of experience

Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena

General project management and planning experience

Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, IRT vendors, etc.)

Basic Qualifications

• Bachelor's degree or equivalent in life science, computer science, business administration or related discipline
• 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)