Senior Manager, Principal Statistician

Job description

**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us contributes. And that makes all the difference. This position is responsible for providing statistical analysis, direction, and training to service clients in Global Product development & Supply (GPS). Support and guidance in relation to study design and data analysis is provided worldwide to the BMS facilities. # Major Duties and Responsibilities: - 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. **Minimum Qualifications:** - 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 **Desired Qualifications:** - 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 *If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.* **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients o