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Key Responsibilities:
- Program and validate tables, listings, figures, and derived datasets using SAS.
- Develop SDTM and ADaM datasets and supporting documentation, and prepare mapping specifications.
- Perform quality control, collaborate on issue resolution, and maintain audit-ready documentation.
Qualifications Required:
- Bachelor’s degree required, Master’s preferred in Statistics, Biostatistics, Mathematics, or Computer Science.
- Minimum 10 years of statistical programming experience in pharmaceutical, biotech, or CRO industries.
- Phase 3 and regulatory submission experience preferred.
Professional Skills:
- Strong SAS programming skills and knowledge of clinical trial processes and regulatory requirements.
- High attention to detail with strong analytical, problem-solving, and communication skills.
- Ability to communicate project status, risks, and issues clearly to stakeholders.
ProKidney
ProKidney is a biotechnology company focused on developing innovative therapies. The organization is an equal opportunity employer with a collaborative culture, operating within the clinical trials and regulatory environment.