Principal Scientist
- Employer
- Bristol Myers Squibb Company
- Location
- New Brunswick, NJ, United States
- Start date
- Apr 23, 2019
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
POSITION ACCOUNTABILITIES
Uses knowledge and expertise of statistics to collaborate with scientists in the design experiments for: formulation development and optimization, process design and optimization, experimental manufacturing campaigns, determining manufacturing design spaces, validation of new assays, and experimental and registrational stability studies. The successful candidate contributes to the CMC development of biological and oral solid drug products.
Analyzes experimental data to support the development of product specifications and regulatory filings.
Engages and leads 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.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS
PhD or MS in Statistics, Biostatistics, or a related field, with a minimum of 7 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 DoE, multivariate statistics, general linear models and mixed models is essential. Reliability statistics knowledge is a plus.
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.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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