Associate Director, Statistical Programming

Bristol-Myers Squibb • Princeton, NJ

429d • Hybrid

About The Position

The Associate Director, Statistical Programming at Bristol Myers Squibb is responsible for providing functional expertise and leadership to clinical project teams, overseeing statistical programming teams, and supporting the development, regulatory approval, and market acceptance of the company's products. This role involves designing, developing, and implementing technical solutions for clinical data integration, analysis, and reporting, while driving innovative strategies and technologies for clinical trial programming. The position also includes functional management responsibilities, focusing on employee development and performance management.

Requirements

• Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 10 years programming experience in industry including support of significant regulatory filings.
• Minimum 5 years of experience in managing technical professionals in a regulated environment.
• Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology.
• Broad expertise in statistical programming and in developing computing strategies.
• In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases.
• Demonstrated proficiency in using SAS to produce analysis datasets and TFLs.
• Demonstrated ability in processing of upstream data and providing deliverables to meet downstream requirements.

Nice To Haves

• Member of industry organizations or presented at Congresses/Conferences.

Responsibilities

• Provide comprehensive programming leadership and support to complex clinical project teams and vendors.
• Drive the development and implementation of innovative strategies and technologies for clinical trial programming.
• Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
• Lead the electronic submission preparation and review.
• Develop unambiguous and robust programming specifications (e.g., ADaM specifications).
• Review planning documents to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.
• Identify, lead, and support opportunities to enhance processes and technology.
• Communicate proactively and effectively around issues and risks and contribute to remediation.

Benefits

• Competitive salary
• Comprehensive health insurance
• Flexible work environment
• Professional development opportunities
• Diversity and inclusion programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree