Senior Principal Biostatistician

Role: Biostatistician overseeing statistical data processing for Phase I–III clinical trials in a biopharma setting, leading project teams and contributing to regulatory activities. Responsibilities: develop and enforce SOPs, participate in pre-IND and NDA activities, author Clinical Development Plans, interpret study results, review statistical summaries, support analysis dataset creation, write statistical analysis plans, and collaborate with multidisciplinary teams on project timelines. Requirements: PhD in Statistics/Biostatistics, several years of industry experience, proficiency in SAS for efficacy analyses, and knowledge of biostatistics, FDA/EMEA guidelines, and drug development processes. Familiarity with multivariate and biomarker analyses is beneficial. Experience in engaging with health authorities and managing projects independently is valued. HighValue: clinical trial phases I–III, biostatistics, regulatory submissions, SAS expertise, experience with efficacy and biomarker analyses, and collaborative project management. WorkSetup: based in Wilmington, DE, requiring minimum 3 days/week onsite, with relocation considerations.