Senior Manager, Biostatistics

Overview: The Senior Manager, Biostatistics provides statistical leadership for complex clinical studies in cell therapy oncology programs. Responsible for study design, statistical analysis, interpretation of results, and communication of statistical findings. Responsibilities: Serve as lead statistician for one or more clinical studies and may support program-level statistical strategy. Lead statistical activities for assigned studies; collaborate with statistical programmers and CRO partners to deliver timely, high-quality statistical outputs. Author and review statistical sections of study protocols, statistical analysis plans, clinical study reports, regulatory submission documents, and publications (abstracts/posters). Maintain current knowledge of statistical methodologies, regulatory guidance, and oncology drug development best practices. Contribute statistical expertise to due diligence and cross-functional evaluations as needed. Create networks with external statistical/programming collaborators and influence internal decisions to ensure quality of study designs/analyses and appropriate conclusions. Contribute to process improvements, standards development, and statistical best practices within Biostatistics. Work effectively in cross-functional teams to resolve study-level operational and scientific challenges. Contribute to knowledge sharing within the department. Required Qualifications/Skills: Ph.D. in Statistics/Biostatistics (3–5 years relevant industry experience in healthcare) or M.S. (6–8 years relevant industry experience in healthcare). Strong experience in oncology clinical development (design and analysis of early- and late-phase trials). Sound theoretical/applied statistics knowledge (including survival analysis, patient-reported outcomes, health economics). Strong decision-making with cross-functional/global perspective; can operate with limited/ambiguous information. Strong verbal, written, and presentation skills. Experience leading collaborative efforts to obtain/analyze complex data. Proficiency in SAS; R familiarity highly desirable. Preferred: Working knowledge of FDA/EMA/ICH statistical guidance; regulatory submission experience (NDA/BLA/MAA) preferred. Work Environment: Professional office or remote work environment; routine use of standard office equipment and technology. #J-18808-Ljbffr Scorpion Therapeutics