Job Details

A company is looking for a Principal Biostatistician to lead statistical strategy and oversight for clinical trial data analysis.Key ResponsibilitiesOversee all statistical aspects of clinical programs from study design to regulatory submissionLead the development of clinical trial protocols, statistical analysis plans, and clinical study reportsCollaborate with cross-functional teams to ensure compliance with regulatory standards and program objectivesRequired QualificationsBachelor's or Master's Degree in Statistics or Biostatistics with relevant experience (10+ years for Bachelor's, 8+ years for Master's)5+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industryExperience as a Lead Biostatistician on multiple concurrent projectsProficiency with CDISC STDM/ADaM standardsWorking knowledge of clinical research and regulatory guidelines