This role involves applying statistical techniques to improve business operations and facilitate better decision-making within the company. The Principal Statistician will provide leadership and statistical subject matter expertise for complex data analysis requests, contributing to strategic planning for non-clinical development plans and regulatory filings. The position requires collaboration with global and site functions to identify areas for improvement using statistical methods, managing multiple studies, and driving innovation in advanced analytics and AI techniques.
Responsibilities
Apply statistical techniques to facilitate better decision-making and improve business operation
Regularly interact with management of different levels in strategy meetings
Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings
Provide leadership and statistical SME support for complex data analysis requests, including critical investigations, specification settings, stability analysis, and yield improvement initiatives
Take accountability for ensuring quality and timely deliverables
Collaborate with global and site functions to identify areas for improvement in yield, robustness, and quality by applying statistical methods
Manage multiple studies to ensure consistency and adherence to standards within manufacturing and quality area
Identify opportunities and drive innovation in advanced analytics and AI techniques through process and quality applications
Act as a scientific and strategic partner to effectively engage with the matrix team in the drug manufacturing process and quality assurance
Connect and communicate with key stakeholders and the leadership team with statistical work in a clear, logical, complete, and transparent manner to support data-driven decisions
Prepare statistical courses and provide training to scientists
Mentor junior staff, proactively help with both their technical and career development, and seek general feedback and technical input from colleagues
Maintain awareness of external trends in advanced analytics and represent BMS at industry forums and conferences
Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions, including R, Python, and JMP
Continue development of various analysis tools to improve the process
Contribute to external and internal statistical community of practice
Requirements
MS (with 8+ years of experience) or PhD (with 2+ years of experience) in Statistics
High degree of technical competence and excellent communication skills, both oral and written
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Able to manage project timeline and quality of deliverables
Knowledgeable in Bayesian statistics
Able to build strong relationships with peers and cross-functional partners to achieve higher performance
Highly motivated to drive innovation by raising the bar and challenging the status quo
Strong leadership skills and experience in working/managing a team
Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment
Experience in a cGMP-regulated environment, preferably gained through direct support of commercial manufacturing
Extensive knowledge of FDA/EMEA cGMPs and other global regulatory compliance guidelines (e.g., ICH) for drug manufacturing, packaging, and distribution
Proficiency in scientific computing/programming/software (R or Python, JMP) and implementation of advanced statistical analysis, data manipulation, graphing & simulation
About the Company
At Bristol Myers Squibb, employees are inspired to discover, develop, and deliver innovative medicines to prevail over serious diseases. The company offers uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
