Principal Programmer, R, SAS at Connect Life Sciences in Philadelphia, Pennsylvania

Posted in Other about 15 hours ago.

Type: full-time





Job Description:

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.

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