Senior Manager, Principal Statistician

• Support the GPS network stakeholders globally to understand their statistical needs and determine sound statistical techniques for use.
• Collaborates with process analytical teams and subject matter experts in Manufacturing and Manufacturing Sciences.
• & Technology to design studies and analyze complex datasets for process robustness and improvement.
• Supports analytical teams in QC and Analytical Sciences & Technology for method lifecycle and reference standard qualification, including method development, qualification, validation, and investigations.
• Develops and selects appropriate statistical methods for the design and analysis of studies and programs to assure batch compliance and prevent rejections, reworks, complaints, and product recalls on a worldwide basis. For example, determining specifications, process capability, sampling plans and expiry/retest periods.
• Conducts thorough and careful analysis of data, gathers critical information, and provides appropriate recommendations and solutions based on corresponding statistical analyses and business needs.
• Demonstrates strong statistical skills while thinking in a clear, decisive manner. Reaches independent, logical solutions.
• Contributes to improvement and standardization of processes, procedures, and systems in relation to Statistics while maintaining flexibility where required.
• Furthers the statistical awareness and statistical process control competency of other BMS personnel; participates in their training and development, as required.
• Creates, communicates, and supports the highest commitment to quality and compliance.
• Supports the BMS BioPharma Behaviors.

• MS (with 2+ years of experience) or PhD (with no additional experience) in Statistics, Biostatistics, or a highly related field.
• Mastery of statistical methods such as Design of Experiments (DOE), regression modeling, variance component analysis, multivariate analysis, process capability, and control charts.
• Advanced skills using one or more statistical packages or languages (e.g., JMP, SAS, or R)
• Ability to analyze and interpret scenarios, and through effective study design and statistical analysis provide answers and appropriate courses of action.
• Ability to instruct non-statisticians in basic & intermediate statistical methods
• Exceptional communication skills, both verbal and written

• Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background
• Knowledge of FDA/EMEA cGMPs and knowledge of other global regulatory compliance guidelines (e.g. ICH, USP) for drug manufacturing, packaging and distribution.
• Ability to work with a wide range of technically and culturally diverse individuals.
• Capable of managing multiple projects in a dynamic environment
• Detail-oriented with a passion for science and data analysis

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.