Sr. Manager Statistical Programming

Role Summary

Senior Manager, Statistical Programming provides programming leadership to clinical project teams, leading statistical programming activities to support development, regulatory submission, and market acceptance of Bristol Myers Squibb products. Responsible for design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data, and for building collaborative relationships within Global Biometrics & Data Sciences and with external vendors. Leads improvement initiatives, proactively plans and identifies risks, and supports change management activities such as communications, training, and stakeholder engagement.

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 and effectively around issues and risks and contributes to its remediation
• Identifies, leads, and supports opportunities to enhance processes and technology

Qualifications

• Required: 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
• Required: For US positions US military experience will be considered towards industry experience
• Required: 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
• Required: Broad expertise in statistical programming and in developing computing strategies
• Required: In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
• Required: Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS Office, XML, Pinnacle 21)
• Required: Demonstrated ability in processing of upstream data (e.g., multiple data forms, workflows, eDC, SDTM); demonstrated ability in providing deliverables to meet downstream requirements (e.g., ADaM, TFLs, e-submission components)
• Required: Demonstrated ability to work in a team environment with clinical team members