Senior Statistician / Principal Statistician

Role Summary

The Senior Statistician / Principal Statistician is a core member of the global statistics group, providing statistical support for drug substances, APIs, and drug products across the internal and external manufacturing network within Bristol Myers Squibb's Manufacturing Sciences and Technology, Global Product Development and Supply (GPS).

Responsibilities

• Apply statistical techniques to facilitate better decision-making and improve business operation.
• Interact with management at various levels in strategy meetings; contribute to strategic planning to optimize non-clinical development plans and assist in creating strategic objectives for regulatory filings.
• Provide leadership and statistical SME support for complex data analyses, including investigations, specification settings, stability analysis, and yield improvement initiatives; ensure quality and timely deliverables.
• Collaborate with global and site functions to identify areas for yield, robustness, and quality improvements using statistical methods.
• Manage multiple studies to ensure consistency and adherence to standards within manufacturing and quality areas.
• Identify opportunities and drive innovation in advanced analytics and AI/ML techniques for process and quality applications.
• Engage as a scientific and strategic partner with matrix teams in the drug manufacturing process and quality assurance.
• Communicate with stakeholders and leadership to support data-driven decisions with clear, logical, complete, and transparent statistical work.
• Prepare statistical courses and provide training to scientists; mentor junior staff and support their technical and career development.
• Maintain awareness of external trends in advanced analytics and represent the company at industry forums; expand expertise in computing tools (e.g., R, Spotfire, SAS) and develop analysis tools to improve processes.
• Contribute to external and internal statistical communities of practice.

Qualifications

• Senior Statistician: Bachelor's degree with 7+ years of experience, or Master's with 4+ years, or PhD with 2+ years.
• Principal Statistician: Bachelor's degree with 9+ years of experience, or Master's with 7+ years, or PhD with 4+ years in Statistics or a related field.
• High technical competence and excellent oral and written communication skills.
• Ability to manage project timelines and deliverable quality.
• Ability to build strong cross-functional relationships; motivated to drive innovation and challenge the status quo.
• Strong leadership skills and experience in managing a team.
• Pharmaceutical or related industry knowledge, including drug development and lifecycle management in a regulated environment.
• Experience in a cGMP-regulated environment, preferably supporting commercial manufacturing.
• Extensive knowledge of FDA/EMEA cGMPs and other global regulatory guidelines (e.g., ICH) for drug manufacturing, packaging, and distribution.
• Proficiency in scientific computing/programming/software (SAS, R, Python, JMP) and implementing advanced statistical analyses, data manipulation, graphing, and simulation.

Education

• Not specified beyond the qualifications above.