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18 days ago
Requirements and responsibilities
We are looking for an experienced Senior Biostatistician to support global oncology clinical trials in a dynamic CRO environment.Key RequirementsMaster's or PhD in Statistics, Biostatistics, or a related quantitative field8+ years of experience in Clinical Research, Pharma, Biotechnology, or CROStrong CRO experience (Highly Preferred)Experience supporting Oncology Clinical TrialsHands-on expertise in SAS (R is a plus)Strong understanding of CDISC (SDTM & ADaM), ICH-GCP, and Regulatory GuidelinesExperience in Statistical Analysis Plans (SAPs), Protocols, and Clinical Study ReportingExperience with Survival Analysis, Time-to-Event Endpoints, and DMC/IDMC Activities is preferredResponsibilitiesLead statistical support across the clinical trial lifecycle—from study design to regulatory submission.Develop and review protocols, SAPs, analysis datasets, tables, listings, and figures.Collaborate with sponsors and cross-functional teams including Clinical Operations, Data Management, Programming, Medical Writing, and Regulatory Affairs.Support oncology endpoints including ORR, PFS, OS, DOR, BOR, CBR, and TTR.Contribute to DMC/IDMC reviews, interim analyses, and final study reporting.Ensure timely, high-quality, and regulatory-compliant statistical deliverables.Mentor junior statisticians and contribute to process improvements.Interested candidates from Ukraine, Bulgaria, Poland, or Romania who meet the above criteria are encouraged to apply by sharing their updated resume at anki@infodigix.com