Principal Programmer, R and Statistical Programming
Position Overview:
We are seeking a highly skilled R and Statistical Programmer to join our [Clinical Research/Biostatistics/Analytics - Specify Department] team. This role will focus on the development, validation, and maintenance of global SAS macros and R programs to support clinical data analysis and regulatory submissions. The ideal candidate will have extensive experience in statistical programming, a solid understanding of regulatory requirements, and a passion for data-driven decision-making.
Key Responsibilities:
- Develop, maintain, and validate global SAS macros and R scripts to streamline clinical data analysis processes.
- Collaborate with statisticians, data managers, and clinical study teams to understand analysis requirements and ensure accurate and timely delivery of outputs.
- Generate and validate datasets, tables, listings, and figures (TLFs) in accordance with study protocols and regulatory submission standards (e.g., CDISC SDTM and ADaM).
- Ensure adherence to relevant regulatory guidelines (e.g., ICH, FDA, EMA) and industry standards for statistical programming.
- Troubleshoot and resolve issues related to data, specifications, or programming logic.
- Contribute to process improvement initiatives and the development of best practices for programming and data analysis.
- Document and maintain version control for R scripts, SAS macros, and associated metadata.
- Support audits, inspections, and regulatory submissions as needed.
Qualifications:
- Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related field.
- 5+ years of experience in statistical programming within the pharmaceutical, biotech, or CRO industry.
- Proficiency in R programming, including the use of R packages for data manipulation, analysis, and visualization.
- Advanced knowledge of SAS programming, including experience developing global SAS macros.
- Hands-on experience with CDISC SDTM and ADaM standards.
- Familiarity with regulatory submission requirements and industry guidelines (e.g., FDA, EMA, ICH).
- Strong problem-solving, analytical, and troubleshooting skills.
- Excellent verbal and written communication skills, with the ability to explain technical concepts to non-technical stakeholders.