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.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Biometric Sciences 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.
• 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 Global Biometric Sciences (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
• 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
• Minimum of 5 years statistical programming experience
• Significant knowledge of SAS software (i.e. Base, Stat, Graph components) with general computing knowledge related to clinical development activities preferred
Ideal Candidates Would Also Have:
• Minimum of 4 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting significant regulatory filings (e.g. NDA, BLA, MAA) preferred
• 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, graduate degree preferred
US military experience will be considered towards industry experience requirements