Real World Principal Biostatistician
Core
Perform advanced scientific statistical analyses for post-marketing areas, clinical trials, and real-world observational studies in drug development.
Role type
Principal Biostatistician (Post-Marketing & Real World Evidence)
Builds
Statistical Analysis Plans, study documents, clinical study reports, and regulatory submissions for drug development.
Domain
Biotechnology / Pharmaceutical / Real World Evidence
Required skills
SAS, R, advanced statistical methods, protocol design, sample size estimation, randomization planning, statistical programming review, regulatory interaction, publication authoring
Preferred skills
Drug discovery and development process knowledge, strategic project management
Technologies
SAS, R
Responsibilities
Design and analyze clinical trials and observational studies; develop statistical sections of protocols and Statistical Analysis Plans; collaborate with Clinical Development, Medical Affairs, and Health Economics teams; contribute to clinical study reports and methodological publications; interact with regulators and payers.
Seniority
Principal, hands-on IC with strategic guidance