Associate Director/Director, Statistical Programming

Description: Job Title: Associate Director/Director, Statistical Programming Company: Immunome, Inc. Location: Bothell, WA Company Overview Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets. Position Overview The Associate Director/Director, Statistical Programming is a leadership role that involves overseeing statistical programming activities within clinical trials. This position collaborates closely with cross-functional teams, including biostatistics, data management, and clinical operations. Here are the key responsibilities and qualifications: Responsibilities Statistical Programming Oversight and Hands-On Programming Lead and manage statistical programming teams (both internal and external) to ensure timely and high-quality deliverables. Review and approve programming plans, specifications, and outputs. When necessary, engage in hands-on statistical programming using tools such as SAS. Develop and validate programs for data analysis, reporting, and visualization. Ensure adherence to regulatory guidelines and industry standards. Leadership and Strategy Provide strategic direction for statistical programming activities across multiple studies or projects. Collaborate with stakeholders to define programming standards, processes, and best practices. Collaboration and Communication Work closely with biostatisticians, clinical teams, and other stakeholders. Provide statistical expertise during study design, data analysis, and reporting. Quality Control Perform quality checks on programming outputs, ensuring accuracy and consistency. Address any discrepancies or issues promptly. Vendor Management Oversee programming activities outsourced to external vendors. Monitor vendor performance and ensure compliance with project timelines. Process Improvement Identify opportunities for process optimization and standardization. Implement best practices and ensure consistency across projects. Stay updated on industry trends, new methodologies, and emerging technologies. Requirements: Education and Experience: Master in Biostatistics, Statistics, or a related field. At least 7 years of statistical programming experience in the pharmaceutical, biotech, or CRO industry. Knowledge and Skills Prior experience in regulatory submissions (e.g. NDA, BLA) a strong plus. Proficiency in statistical programming languages (e.g., SAS, R). Strong understanding of clinical trial data and regulatory requirements Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines. Comprehensive knowledge of the CDISC standards and concepts, and the current best practice in the industry. Excellent leadership, communication, and problem-solving skills. Attention to detail including proven ability to manage some competing priorities. E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Salary Range $170,000 - $228,300