Senior Statistical Programmer – Full-Service CRO
Remote
We are seeking a Senior Statistical Programmer to join a leading full-service CRO specializing in multiple therapeutic areas. This is a fully remote role for an experienced professional with a Master’s or Ph.D. and at least 8 years of statistical programming experience in clinical trials.
Key Responsibilities
- Develop, validate, and maintain SDTM and ADaM datasets and statistical programming deliverables following CDISC standards.
- Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and regulatory submissions.
- Provide statistical programming support for Phase I-III clinical trials across multiple therapeutic areas.
- Collaborate with biostatisticians, data managers, and clinical teams to ensure high-quality data analysis and reporting.
- Contribute to the development and review of statistical programming plans (SPPs) and study protocols.
- Support regulatory submissions (e.g., FDA, EMA) by preparing required datasets and documentation.
- Troubleshoot programming issues, implement quality control (QC) checks, and ensure compliance with GCP, ICH, and regulatory guidelines.
- Mentor and support junior programmers, providing guidance on best practices and efficiency improvements.
Qualifications
- Master’s or Ph.D. in Biostatistics, Statistics, Computer Science, or a related field.
- Minimum 8 years of statistical programming experience in a CRO, biotech, or pharmaceutical setting.
- Strong proficiency in SAS programming with experience in CDISC standards (SDTM, ADaM).
- Experience programming for Phase I-III clinical trials across multiple therapeutic areas.
- Knowledge of FDA and EMA submission requirements, including define.xml and eCTD formatting.
- Ability to work independently in a remote, fast-paced environment while collaborating with cross-functional teams.
- Excellent problem-solving skills, attention to detail, and ability to manage multiple projects simultaneously.