Director BIOSTATISTICS
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, US
- Start date
- Dec 4, 2018
View more
- Discipline
- Science/R&D, Biostatistics
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
- Provides strategic, scientific and statistical expertise as a core member of Translational Medicine Teams.
- Provides statistical expertise and guidance on the scientific and statistical strategy and execution of the strategy for the development of candidate predictive biomarker(s) and precision medicine.
- Partners with Biomarkers Leads and Translational Sciences groups to develop and optimize biomarker assays, assess and optimize biomarker technology platforms, including technology platform due diligence.
- Partners with Biomarkers and Precision Medicine in discovering potential pharmacodiagnostic biomarkers to provide statistical expertise and rigor in the design of studies, statistical analysis and inferences, including control for multiplicity and mitigation for overfitting when applicable to biomarker signature efforts.
- Partners with GBS Leads and protocol statisticians in reviewing protocols and statistical analysis plans (SAP) and providing biomarker/diagnostic expertise and guidance during SAP development.
- Scientific and strategic input into pre-Investigational Device Exemption and HA documents and therapeutic program milestone presentations containing pharmacodiagnostic plans.
- Providing scientific and strategic input during development and execution phase of diagnostic registration and regulatory reviews, including interactions with diagnostic partner companies and Health Authorities.
- Contributes to the evolving pharmacodiagnostics and precision medicine statistical landscape internally and externally by providing education internally and attending and presenting at workshops and meetings and sharing the learnings.
Requirements:
- Ph.D. or equivalent in statistics or related field.
- > 12 years of clinical, pharmacodiagnostics, biomarkers discovery and development, regulatory interactions, filing support experience.
- Expert knowledge of the precision medicine literature and statistical approaches to discovering, developing and validating companion diagnostics and biomarkers, including regulatory requirements.
- Strong technical skills, including but not limited to general linear and mixed models, survival analysis, high-dimensional data analysis, bayesian statistics, design of experiments, statistical methods for biomarker assay development and validation and joint evaluation of therapies for efficacy and safety with biomarkers for prediction and classification.
- Excellent verbal and written communications skills.
- Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
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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