Anunciada dia A 33 min atrás
Missão do cargo
Alsinova is looking for a Principal Biostatistician to lead statistical activities on a pivotal Phase III oncology study. This is a hands-on leadership role on sponsor side. The position is remote on US time zone.ResponsibilitiesLead all statistical deliverables from study start-up through database lock (SAP, TLF specs, analysis oversight)Contribute to protocol design, randomization, and sample size planning (ICH E9(R1))Provide statistical review of regulatory documents and support CSR/submission activitiesMentor junior biostatisticians and programmers as neededRequirementsMSc or PhD in Statistics or BiostatisticsSubstantial oncology clinical trial experience with direct ownership of Phase II/III studiesStrong delivery skills in fast-paced environmentsSolid knowledge of oncology endpoints (OS, PFS, ORR, RECIST) and FDA/EMA guidelinesNice to haveExperience leading a Phase III oncology study from start-up
