Principal Statistician

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.
• Provides leadership and statistical SME support for complex data analysis requests, including critical investigations, specification settings, stability analysis, and yield improvement initiatives. Takes accountability for ensuring quality and timely deliverables.
• Collaborates with global and site functions to identify areas for improvement in yield, robustness, and quality by applying statistical methods.
• Manages 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. Examples of such tools include R, Python, and JMP. Continue development of various analysis tools to improve the process.
• Contributes to external and internal statistical community of practice.

Qualifications

• 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
• 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
• Have 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.