Principal Biostatistician (VAX)
Core
Lead biostatistics and programming activities across the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC) to support clinical study design, execution, and reporting for vaccine development.
Role type
Principal Biostatistician (Vaccines R&D)
Builds
Clinical study reports, Integrated Analysis Plans for Safety/Immunology, CDISC compliant data packages, and statistical sections for protocols and submissions.
Domain
Biopharmaceuticals / Vaccines / Clinical Trials
Required skills
Clinical trial design and statistical methodology, Statistical Analysis Plan (SAP) development, CDISC standards (SDTM/ADaM/SEND), SAS programming, R programming, complex exploratory data analysis, study reporting and interpretation.
Preferred skills
Experience in e-submission statistical activities (ISS, ISE, ISI), leading programmers, resourcing strategy implementation.
Technologies
SAS, R, CDISC (SDTM, ADaM, SEND, define.xml)
Responsibilities
Develop statistical sections in protocols and Statistical Analysis Plans; perform data analysis and ensure clinical study report integrity; conduct complex exploratory and ad-hoc analyses; collaborate with programming teams on variable definitions and quality control; interpret results in line with competition and sponsored studies.
Seniority
Senior, hands-on IC with leadership responsibilities