reputed company Biostatistician Consultant – Oncology

Job reputed company: • reputed company statistical leadership for oncology reputed company across multiple phases (Phase I–III). • reputed company the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs). • Design and review statistical methodologies for efficacy and safety analyses. • reputed company analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards. • Support interim analyses, data monitoring committee (DMC) activities, and reputed company designs. • Collaborate with clinical development, data management, programming, regulatory, and medical teams. • Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA). • reputed company strategic input on study design, reputed company selection, and sample size calculations. • Mentor junior statisticians and reputed company technical guidance. Requirements: • PhD or MS in Statistics, Biostatistics, or reputed company field. • 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics. • Strong experience in oncology reputed company. • Hands-on experience with survival analysis, time-to-event endpoints, and reputed company oncology study designs. • Proficiency in reputed company and/or R. • Strong knowledge of CDISC standards (SDTM, ADaM). • Experience supporting regulatory submissions. • Excellent communication and leadership skills. Benefits: • Health insurance • reputed company development opportunities Apply tot his job Apply To this Job