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, statistical analysis plans, integrated safety/immunology summaries, and CDISC-compliant data packages for regulatory submission.
Domain
Healthcare / Vaccines / Clinical Trials
Required skills
Clinical trial design and statistical methodology, Sample size calculation, Statistical Analysis Plan (SAP) development, CDISC standards (SDTM/ADaM/SEND), SAS programming, R programming, Complex exploratory data analysis, Regulatory submission support (ISS/ISE/ISI), Cross-functional team leadership
Preferred skills
PhD in Statistics/Mathematics, Experience in non-standard trial designs, Vendor management for randomization
Technologies
SAS, R, CDISC (SDTM/ADaM/SEND), Define.xml
Responsibilities
Develop statistical sections in protocols and Statistical Analysis Plans; Perform data analysis and interpret results for clinical study reports; Lead programmers in e-submission statistical activities; Propose and execute complex exploratory and ad-hoc analyses; Collaborate with safety monitoring and cross-functional teams on study design and execution.
Seniority
Principal, hands-on IC with leadership responsibilities