Statistical programmers provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of BMS products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Statistical programmers develop collaborative relationships and work effectively within GBS, with external vendors and members of cross-functional development teams. This position reports to a Statistical Programming Manager and has no direct supervisory responsibilities.
- Communicates effectively with GBS project and functional leadership concerning project issues (e.g. data, technical, timelines).
- Ensures alignment with Planning & Execution Lead with regard to priorities and scope of work assignments. Proactively, informs Planning & Execution Lead of issues/risks to the project and potential remediations.
- Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis. Drives the development and implementation of innovative strategies and technologies for flexible and global clinical trial programming.
- Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.
- Supports the development of unambiguous and robust programming specifications for internal and external programming work.
- Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers. When necessary, provides technical guidance to vendors supporting analysis and reporting (A&R) work. Provides support for acceptance of vendor deliverables.
- Builds successful partnerships and seamless interfaces within GBS and the broader R&D organization. Provides timely and effective communication to project team members, highlighting GBS goals and priorities, ensuring work efforts parallel departmental objectives.
- Provides leadership for ensuring quality of GBS deliverables by consistently applying A&R standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
- Identifies opportunities for increased efficiency and consistency within GBS and across R&D. Contributes to globalization, improvement and standardization of processes, standards and tools.