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 identify 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).
Basic Qualifications
Bachelors degree or equivalent in life science, computer science, business administration or 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 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, central labs, imaging vendors, IRT vendors, etc.)
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)
