Sr. Manager Statistical Programming

Role Summary

Senior Manager of Statistical Programming provides comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. Responsible for design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Develops collaborative relationships within Global Biometrics & Data Sciences (GBDS), with external vendors and cross-functional development teams. Also supports and leads improvement initiatives, proactively planning, implementing, identifying issues/risks and providing remediation strategies; leads and supports change management processes.

Responsibilities

• Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
• Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
• Leads / supports the electronic submission preparation and review
• Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; assesses document robustness and impact on programming activities
• Communicates proactively around issues and risks and contributes to remediation

Qualifications

• Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required
• At least 7 years programming experience in industry including support of significant regulatory filings
• For US positions US military experience will be considered towards industry experience
• Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
• Broad expertise in statistical programming and in developing computing strategies
• In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
• Proven proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools (e.g., MS Office, XML, Pinnacle 21)
• Ability to process upstream data (e.g., multiple data forms, workflows, eDC, SDTM) and provide deliverables for downstream requirements (e.g., ADaM, TFLs, e-submission components)
• Demonstrated ability to work in a team environment with clinical team members

Skills

• Statistical programming
• ADaM, SDTM, TFLs
• SAS programming
• CDISC standards
• Regulatory submission support
• Cross-functional collaboration
• Problem solving and risk remediation

Education

• Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences (required)