The Global Biometric Sciences (GBS) Statistical Programming Technical Manager provides functional expertise and leadership to Statistical Programming and Technology (SPT) colleagues while delivering comprehensive programming expertise to clinical project teams in support of development, regulatory approval and market acceptance of Bristol-Myers Squibb (BMS) products.
Support and provide technical guidance to SPT organization as required
Drug Development Team, GBS Planning & Execution Leads, Statisticians, Statistical Programmers and vendors
- Manage an assigned group of Statistical Programmers to establish employees’ objectives and manage their performance. Also conducts 1-1 developmental discussions, mid-year reviews, and end of year discussions
- Ensures quality of GBS deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices
- Provides comprehensive programming leadership and support to clinical project teams, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, corporate and departmental SOPs and work practices
- Drives the development and implementation of innovative strategies and technologies for clinical trial programming
- Provides technical guidance to vendors concerning project standards, programming conventions/specifications and programming practices to ensure efficient and integrated project computing strategies
- Reviews planning documents (e.g. statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives. These reviews focus on clarity, integrity and completeness of programming assumptions and requirements, and ensure compliance with standards
- Develops unambiguous and robust programming specifications for internal and external programming work
- Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and BMS standards
- Understands software development methodologies and appropriately applies those methodologies
- Identifies opportunities for increased efficiency and consistency within GBS and provides SME support to continuous improvement initiatives within and beyond GBS
- Builds successful partnerships and seamless interfaces within the department and the broader research and development organization. Communicates proactively and effectively around issues and risks and contributes to remediation
Ideal Candidates Would Also Have
- Graduate degree in statistics, mathematics, computer science or equivalent experience.
- At least 6 years clinical/statistical programming experience within pharmaceutical clinical development including support of significant regulatory filings
- Broad expertise in statistical programming and developing computing strategies for statistical analysis & reporting
- Expert knowledge of Base SAS and advanced knowledge of SAS Stat and Graph
- Extensive knowledge of drug development process, clinical trial methodology, statistical concepts used in the analysis and submission of clinical data, and knowledge of industry practices and regulatory requirements.
- Management experience supervising technical professionals
US military experience will be considered towards industry and professional experience requirements