Join Bristol Myers Squibb: Transforming Lives, Including Yours

Challenging. Meaningful. Life-changing. These aren’t just words; they’re the foundation of your career with us. At Bristol Myers Squibb, you’ll be a part of uniquely interesting work every day, in every department. From production optimization to groundbreaking advancements in cell therapy, your efforts will transform lives—both yours and our patients'. Thrive and grow with numerous opportunities alongside diverse, high-achieving teams. Take your career further than you imagined.

We recognize the value of balance and flexibility in the workplace. That’s why Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs to support your professional and personal goals.

Position Summary: Associate Director, Statistical Programming

As an Associate Director, Statistical Programming, you will provide functional expertise and leadership to clinical project teams. Your role involves leading statistical programming teams and supporting the development, regulatory approval, and market acceptance of Bristol Myers Squibb products. You will be responsible for designing, developing, and implementing technical solutions for integrating, analyzing, and reporting clinical data. Additionally, you will drive the development and implementation of innovative strategies and technologies for clinical trial programming.

Key Responsibilities

Project Responsibilities

• Lead and support complex clinical project teams and vendors by deploying programming strategies, standards, specifications, and analyses to meet regulatory requirements, SOPs, and work practices.
• Develop innovative strategies and technologies for clinical trial programming.
• Create, validate, troubleshoot, and maintain complex programs and utilities according to predefined specifications and standards.
• Lead preparation and review of electronic submissions.
• Create unambiguous and robust programming specifications, including ADaM specifications.
• Support global regulatory submissions and approvals of Cell Therapy Products.
• Develop standards for Cell Therapy Products.
• Review planning documents to ensure alignment with project objectives and programming requirements.

Improvement Responsibilities

• Identify, lead, and support opportunities to enhance processes and technology.
• Communicate proactively about issues and risks, contributing to their remediation.

Managerial Responsibilities

• Recruit, manage, develop, evaluate, reward, motivate, and retain direct reports, enhancing capabilities within GBDS.
• Conduct objective setting, performance check-ins, and year-end discussions.
• Hold regular meetings with direct reports for project updates, development needs, and issue resolution; provide real-time coaching and feedback.
• Communicate with management regarding promotions, performance concerns, and retention risks.
• Build and maintain relationships with stakeholders and peers to achieve cross-functional strategies and objectives.
• Act as an extended member of the Statistical Programming Leadership Team to share and build the line function vision.

Minimum Requirements

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences.
• At least 10 years of programming experience in the industry, including significant regulatory filings, with a minimum of 5 years managing technical professionals in a regulated environment.
• Proficient knowledge of the drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology.
• Broad expertise in statistical programming and developing computing strategies.
• In-depth understanding of clinical data structures and relational databases.
• Proficiency in using SAS and other software tools (e.g., MS Office, XML, Pinnacle 21).
• Ability to process upstream data and provide deliverables to meet downstream requirements.
• Demonstrated teamwork skills within clinical team members.

Preferred Requirements

• Involvement in industry organizations or presentations at Congresses/Conferences.
• Encourage applications from individuals whose skills align with the role, even if the resume doesn’t perfectly match.

Uniquely Interesting Work, Life-changing Careers

Our vision, “Transforming patients’ lives through science™,”