Senior Manager, Statistical Programming Expert
19 hours ago
Job Summary
Bristol Myers Squibb is seeking a Senior Manager of Statistical Programming to provide comprehensive programming expertise to clinical project teams. This position is responsible for leading statistical programming teams and supporting the development, regulatory approval, and market acceptance of Bristol Myers Squibb products.
Key Responsibilities:
- Provides 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.
- Develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards.
- Leads the electronic submission preparation and review.
- Develops unambiguous and robust programming specifications.
- Reviews key planning documents to align with project objectives and ensures clarity and completeness of programming assumptions and requirements.
- Communicates proactively and effectively around issues and risks and contributes to their remediation.
Requirements:
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required.
- At least 8 years of programming experience in industry, including support of significant regulatory filings.
- 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 and relational databases.
- Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications.
Preferred Requirements:
- Management experience supervising technical professionals.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our employees are empowered to apply their individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
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