Principal Scientist, Biostatistics, Late-Stage Clinical Development
Core
Statistical lead for late-stage clinical development of drugs and vaccines, designing trials, analyzing data, and ensuring regulatory compliance.
Role type
Principal Scientist, Biostatistics (Late-Stage Clinical Development)
Builds
Clinical trial protocols, statistical analysis plans, and regulatory review aids for drug/vaccine programs.
Domain
Biopharmaceuticals / Clinical Trials (Phase II-V)
Required skills
Statistical analysis methodologies, experimental design, project management, SAS/R, worldwide regulatory requirements, clinical trial expertise (Phase II-V), statistical programming (via careerplan.io/jobs/R414604-2-principal-scientist-biostatistics-late-stage-clinical-development-at-msd)
Preferred skills
Peer-reviewed publications, disease biology understanding, drug discovery knowledge
Technologies
SAS, R
Responsibilities
Lead statistical activities for drug/vaccine projects; design and analyze clinical trials; develop protocols and analysis plans; mentor junior staff; prepare reports for management and regulatory agencies; evaluate software and propose novel statistical methods.
Seniority
Principal, hands-on IC with mentorship