Manager - Statistical Programming

Job Summary

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 DQS, with external vendors and members of cross-functional development teams. This position reports to a Statistical Programming Manager and has no direct supervisory responsibilities.

Duties/Responsibilities

• 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 clinical trial programming.
• Reviews key planning documents (e. g. , protocol, 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.
• Communicates effectively with DQS project and functional leadership concerning project issues (e. g. data, technical, timelines).
• 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 DQS and the broader Global Drug Development (GDD) organization. Provides timely and effective communication to project team members, highlighting DQS goals and priorities, ensuring work efforts parallel departmental objectives.
• Provides leadership for ensuring quality of DQS 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 DQS and across GDD. Contributes to globalization, improvement and standardization of processes, standards, and tools.
• Contributes to the technical evaluation of candidates and supports their successful integration into the organization.

Degree Requirements

• Undergraduate or Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred

Experience Requirement

• 5 - 8 years clinical/statistical programming experience within pharmaceutical clinical development
• Oncology Experience preferred

Key Competency Requirements

• Significant knowledge of SAS software (i. e. Base, Stat, Graph components) and general computing as related to clinical drug development.
• Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
• Ability to work successfully within cross-functional teams leads to successful global regulatory filings and approvals.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities.
• Excellent verbal and written communications skills