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.