Principal Statistical Analyst
We are seeking an experienced Principal Statistical Analyst to support the analysis, validation, and reporting of clinical trial data in a dynamic and collaborative research environment. This individual will play a key role in delivering high-quality programming outputs, ensuring data integrity, and supporting regulatory and clinical development activities across multiple studies.
Key Responsibilities
Develop and/or independently validate SAS programs used to generate analysis datasets, tables, listings, figures (TLFs), and other clinical trial deliverables. Create and maintain analysis dataset specifications and supporting documentation. Ensure timely, accurate, and high-quality delivery of programming outputs across assigned studies and projects. Follow established programming standards, processes, and best practices. Perform quality control reviews of clinical data outputs and related documentation to support internal decision-making and external regulatory submissions. Support the development of CDISC-compliant deliverables, including SDTM and ADaM datasets, associated documentation, and analysis outputs. Contribute to clinical study reporting, regulatory submissions, publications, and other research-related deliverables. Produce and validate ad hoc analyses, data reviews, and presentation materials for cross-functional stakeholders. Review Statistical Analysis Plans (SAPs), programming specifications, study reports, presentations, and related documents to ensure accuracy and consistency. Collaborate closely with statisticians, data management, clinical teams, and other functional groups to support study objectives.
Qualifications
Bachelor's or Master's degree in Statistics, Mathematics, Biostatistics, Computer Science, Life Sciences, or a related field. 14+ years of statistical programming experience within the pharmaceutical, biotechnology, CRO, or clinical research industry. Extensive hands-on experience using SAS for clinical trial data analysis and reporting. Strong knowledge of CDISC standards, including SDTM and ADaM. Experience supporting regulatory submissions and clinical study reporting activities. Excellent written and verbal communication skills. Proven ability to manage multiple priorities, work independently, and thrive in a cross-functional team environment. Industry experience supporting clinical development programs is required.
Preferred Qualifications
Experience supporting oncology clinical trials. Strong attention to detail with a commitment to data quality and regulatory compliance. Demonstrated ability to learn quickly and adapt to changing priorities. Collaborative mindset with a track record of working effectively across teams. Interest in leveraging innovative tools, technologies, and processes to improve efficiency and quality. This is an excellent opportunity for a senior-level programming professional who enjoys working in a fast-paced clinical development environment and contributing to the successful delivery of high-impact research programs.