Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
The Bristol-Myers Squibb North America Capability Center is a state-of-the-art facility in Tampa, Florida, providing strategic capabilities for delivering end-to-end process excellence and innovation. The center provides high knowledge-based capabilities and services across multiple disciplines and is part of our ongoing efforts in continuous process improvement. At the North America Capability Center we continue to explore ways to simplify processes and increase the efficiency and effectiveness of our operations.
The Principal Statistical Programmer provides comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol-Myers Squibb (BMS) products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data, including writing and adjusting computer software code to create or modify these technical solutions.
Qualifications: Minimum Requirements:
- Creates new programs, troubleshoots and updates code written by colleagues in support of design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data
- Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
- 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
- Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
- Provides leadership for ensuring quality of GBS deliverables by consistently applying Analysis &Reporting (‘A&R’) standards and complying with regulatory requirements, protocols, guidance and corporate and departmental SOPs and work practices
- Identifies opportunities for increased efficiency and consistency within GBS and across Research & Development (‘R&D’)
- Independently leads and / or performs programming assignments across multiple projects with minimal supervision
- Develops and / or maintains complex programs and utilities in accordance with predefined specifications and BMS standards
- Reviews planning documents to assess compliance with standards, impacts on programming activities and project risks
- Identifies opportunities for increased efficiency and consistency within GBS and our interactions with strategic vendors
Ideal Candidates Would Also Have
- Minimum of 4 years statistical programming experience in industry, US Military or Academic environment
- Significant knowledge of SAS (' Statistical Analysis Software'): i.e. Base, Stat, Graph components, with general computing knowledge related to clinical development activities preferred
- Minimum of 4 years clinical / statistical programming experience related to pharmaceutical clinical development - Supporting significant regulatory filings (e.g. NDA, BLA, MAA)* preferred
- Academic environment experience or related coursework will be considered towards experience requirements
- Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements preferred
- Bachelor's degree in statistics, biostatistics, mathematics, computer science required
- Advanced post-graduate qualifications preferred, and would be considered in relation to minimum years' programming experience
- US military experience will be considered towards industry experience requirements