Principal Scientist, Drug Product Development Statisticia

Key Skills

Data science techniques, Data Visualization, Design, Effective communication skills, JMP, Product Development, R Programming, SAS, Teamwork

Job Description

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 rich in diversity. 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.

Principal Scientist, Drug Product Development Statistician

Bristol Myers Squibb is seeking an experienced Statistician to join the Engineering Technologies group within the Drug Product Development function. Are you looking for a patient-centric company that will inspire you and support your career? Then join our diverse and innovative team, where we provide rigorous statistical and data science solutions to a wide array of assignments, ranging from development to commercial manufacturing support.

Responsibilities:

• Uses knowledge and expertise of statistics to collaborate with scientists in application of statistics to Drug Product Development: Quality by Design, formulation development and optimization, process design and optimization, experimental manufacturing campaigns, determining manufacturing design spaces, validation and development of analytical assays, experimental and registrational stability studies, probabilistic assessment of risk for critical quality attributes. The successful candidate contributes to the Chemistry, Manufacturing and Controls (CMC) aspects of biological and oral solid drug products.
• Analyzes experimental data to support the development of product specifications and regulatory filings.
• Engages in scientific and technical discussions with multi-disciplinary team members to move forward with speed and accountability.
• Clearly communicates and documents results to stakeholders with diverse backgrounds, including non-technical audiences.
• Develops visualization techniques to facilitate interpretation of experimental data and models by non-statisticians. Trains scientists in data analysis, statistics, and visualization.
• Applies regulatory guidelines to work and keeps abreast of technical and regulatory advancements. Authors source documents used in CMC registrational filings. Assists in developing responses to health agencies.
• Participates in functional and cross-functional initiatives, including process and quality improvements.

Requirements:

• PhD or MS in Statistics, Biostatistics, or a related field, with a minimum of 4 years of relevant industry experience. Candidates with documented equivalent experience in an applied statistical setting will be considered.
• Pharmaceutical development experience and knowledge of CMC is desired. Expertise in other scientific/engineering/computing areas is a plus.
• Advanced knowledge of Design of Experiments (DoE), multivariate statistics, general linear models and mixed models is essential.
• Candidate must be proficient with SAS. Experience with R or S-Plus, and/or JMP is desired.
• Understanding of regulatory guidelines (e.g. cGMP and ICH guidance) that impact the use of statistical analysis for setting specifications and predicting shelf life is preferred.
• A successful candidate will have excellent computational, written and verbal communication skills, strong organizational abilities and an ability to work with a diverse group of scientists and engineers.