Senior Manager- Statistical Programming Lead
1 month ago
Job Summary: We are seeking a highly skilled Senior Manager- Statistical Programming Lead to join our team at Bristol Myers Squibb. As a key member of our clinical programming team, you will be responsible for providing leadership and support to clinical project teams and vendors, ensuring compliance with regulatory requirements, SOPs, and work practices.
Key Responsibilities:
- Develop and implement programming strategies, standards, and specifications to ensure compliance with regulatory requirements.
- Lead the development, validation, and maintenance of complex programs and utilities in accordance with predefined specifications and standards.
- Oversee the electronic submission preparation and review process.
- Develop unambiguous and robust programming specifications, such as ADaM specifications.
- Review key planning documents to ensure alignment with project objectives and programming assumptions.
- Communicate proactively and effectively around issues and risks, contributing to their remediation.
Requirements:
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences.
- At least 9 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.
- Broad expertise in statistical programming and computing strategies.
- In-depth understanding of clinical data structure and relational databases.
- Demonstrated proficiency in using SAS and other software tools and applications.
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