Principal Biostatistician for inhouse project (Permanent role)
Core
Lead statistical activities for clinical trials in immunology and oncology, ensuring regulatory compliance and delivering analysis outputs.
Role type
Principal Biostatistician
Builds
Production ML models | product features | dashboards & analysis
Domain
Biotechnology / Clinical Trials / Immunology / Oncology
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Statistical Analysis Plans (SAPs), Analysis Database Specifications (ADS), clinical study reports, SAS programming, regulatory standards (FDA, ICH, GCP), cross-functional collaboration, statistical strategy
Preferred skills
Phase II–III clinical trial leadership, regulatory agency interaction
Technologies
SAS
Responsibilities
Lead and provide statistical support for clinical studies in Immunology or other therapeutic areas; Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables; Author and review key statistical documents including SAPs, ADS, and clinical study reports; Review and interpret analysis outputs ensuring accuracy and regulatory compliance; Provide guidance and oversight to statistical programmers; Communicate statistical concepts and results to technical and non-technical stakeholders; Ensure adherence to regulatory standards and company SOPs
Seniority
Principal, hands-on IC
