Senior Manager, Statistical Programming - Lead CDISC Data

Bristol Myers Squibb; Princeton (NJ); On-site; USD 145,000 - 176,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager - Statistical Programming to lead programming teams within clinical projects in Princeton, NJ. You will design, develop and implement technical solutions for integrating, analyzing and reporting clinical data to support development, regulatory submissions and market access.

You will build collaborative relationships across Data & Quantitative Sciences, vendors and cross-functional teams, drive standardization, risk mitigation and process

Qualifications

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences.
• At least 6 years programming experience in industry including support of significant regulatory filings.
• Proficient knowledge of drug development process, regulatory guidance, SDTM, ADaM.
• Experience leading programming teams and projects.
• Strong communication and collaboration skills.

Responsibilities

• Provide programming leadership to clinical teams and vendors, ensuring regulatory compliance.
• Develop, validate, and maintain complex programs and utilities.
• Lead submission preparation and review activities.
• Create robust programming specifications (e.g., ADaM).
• Communicate proactively about issues and risks.
• Identify and drive process and technology improvements.
• Support change management through training and stakeholder engagement.

Skills

SAS programming

CDISC standards

Statistical programming leadership

Regulatory submissions

Communication

Education

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences

Tools

SAS

Pinnacle 21

XML

MS Office

Job description

Bristol Myers Squibb is seeking a Senior Manager - Statistical Programming to lead programming teams within clinical projects in Princeton, NJ. You will design, develop and implement technical solutions for integrating, analyzing and reporting clinical data to support development, regulatory submissions and market access.

You will build collaborative relationships across Data & Quantitative Sciences, vendors and cross-functional teams, drive standardization, risk mitigation and process