Principal Biostatistician (VAX)
Core
Lead end-to-end biostatistics and programming activities for clinical studies in the Vaccines R&D value chain, from design to submission.
Role type
Principal Biostatistician (Vaccines)
Builds
Clinical study deliverables, statistical analysis plans, safety/immunology summaries, and CDISC-compliant data packages for regulatory submission.
Domain
Healthcare / Vaccines R&D / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design, sample size calculation, Statistical Analysis Plan (SAP) development, complex exploratory data analysis, CDISC standards (SDTM/ADaM/SEND), SAS, R, project management, statistical interpretation
Preferred skills
Experience leading programmers, e-submission activities (ISS/ISE/ISI), resourcing strategy
Technologies
SAS, R
Responsibilities
Support clinical study design and setup; develop statistical sections in protocols and SAPs; perform data analysis and interpret results; coordinate with programming teams for CDISC-compliant data packages; conduct complex exploratory and ad-hoc analyses; present statistical insights to senior leadership.
Seniority
Principal, hands-on IC with leadership responsibilities
