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.