Provides advanced computer programming support for some or all of the following activities: creation and maintenance of programs used for data entry, data management, data validation, statistical report generation, and program validation. Assists Data Management and Biostatistics with developing tools and techniques for improving process efficiencies. Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget. Acts as Programming Lead or Biostats Project Lead on projects. Acts in a consult or mentor role for all junior staff as needed on programming and/or leadership topics. Input into resource allocation. Reviews and makes recommendations for process development and improvement. Provides input to the bidding process.
Understands and follows department's working practice documents and SOPs, and contribute to their development as needed.
- Understands and follows appropriate corporate SOPs.
- Works directly with project team leaders and client representatives to assess and develop project goals and timelines.
- Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases.
- Independently creates, executes, maintains, and validates programs that generate listings, tables and figures using SAS.
- Supervises and performs other programming tasks as necessary to support Clinical Data Management and Biostatistics.
- Assesses and ensures the validity of all program output.
- Serves as a project lead and oversees work of other programmers on team.
- Manages assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
- Assumes leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed.
- Documents all work; manages assignments to meet timelines and produces high quality deliverables.
- Demonstrates a good understanding of the role of the programmer in the overall process.
- Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
- Works efficiently and effectively with little direct supervision.
- Supervises, trains and mentors other programmers.