Principal Statistical Programmer (Manager)
Job Title: Principal Statistical Programmer (Manager)
Report to: Senior Manager, Programming
- Configure software and write programs that produce deliverables such as data sets, tables, listings, and graphs to support research and development projects, including materials for internal decision-making and for submission to regulatory agencies
- Lead project workload, including prioritization to meet company objectives, estimation of resources required to meet timelines, securing team resources, defining quality and completion criteria and tracking team progress to completion
- Attend multi-disciplinary team meetings, representing the programming function.
- Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Transfer Specification, SAPs, etc.)
- Oversee work of internal contract programmers and external vendors.
- Perform ad hoc analyses and data validation using pharmaceutical industry knowledge, experience and advance statistical analytics
- Provide training and development of less experienced staff within the department.
- Bachelor’s Degree in Computer Science, Statistics, Mathematics, Public Health or other relevant scientific fields; Master’s Degree preferred
- Minimum of 6 years of experience in developing software for clinical trials using the SAS system
- Expert in programming with SAS. Knowledge of additional programming languages a plus.
- Good knowledge of statistics and drug development process
- Experience as a lead programmer for NDAs/BLAs
- Experience overseeing the work of internal contractors and external vendors (CROs)
- Familiarity with CDISC standards, including SDTM and ADaM models
- Solid verbal and written communication skills