Principal Scientist, Drug Product Development Statistician

Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: June 21, 2022

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.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.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.**Company:** Bristol Myers Squibb**Req Number:** R1557662**Updated:** 2022-06-17 04:02:45.945 UTC**Location:** New Brunswick,New JerseyBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Keywords: Bristol Myers Squibb, New Brunswick , Principal Scientist, Drug Product Development Statistician, Other , New Brunswick, New Jersey