Principal Scientist, Biostatistics, Clinical Safety Statistics
merckRahway, NJ
Principal Scientist, Biostatistics, Clinical Safety Statistics
merckRahway, NJLead L6
Research and Development in Biotechnology (except Nanobiotechnology)Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)Other Scientific and Technical Consulting Services
APPLY NOWRoleLead statistical safety evaluation within the Clinical Safety Statistics (CSS) group for Oncology Therapeutic Area programs, providing expertise in safety monitoring, analysis, and risk assessments throughout product development and post-marketing.
Responsibilitiesdevelop strategic safety plans
partner with cross-functional teams (Risk Management, Epidemiology, Data Programming)
design innovative statistical methods
ensure compliance with regulatory standards
communicate safety findings to stakeholders
Requirements:
PhD or MSc in statistics, biostatistics, or related, with at least 6 years (PhD) or 9 years (Master's) of relevant experience
strong knowledge of survival analysis, meta-analysis, Bayesian methods, SAS or R proficiency, and regulatory safety data analysis
Preferredunderstanding of drug/vaccine development stages from preclinical to post-marketing
interest in novel statistical/machine learning methods
publication record
High-ValueOncology therapeutic area
safety analysis
regulatory compliance
clinical trial and real-world data expertise
experience with safety monitoring tools
Work Setuphybrid in the US; approximately 10% travel.
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Level
Lead L6
Location
Rahway, NJ
Occupation
Biostatisticians
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Posted
2 days ago