Sr. Statistical Programmer

Katalyst CRO

Edison, NJ (+1 other)Posted May 5, 2026

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Qualifications

  • •Bachelor’s or master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific discipline; or a combination of education, training and experience that enables effective performance in this role
  • •5+ years of statistical programming experience within the pharmaceutical, biotech, or CRO industry, preferably in CNS trials
  • •Experience leading programming efforts for clinical trials, including dataset development, TLF production, and QC oversight
  • •Advanced proficiency in SAS, with hands‑on experience using CDISC SDTM and ADaM standards
  • •Experience with R or Python for data manipulation, automation, or reporting is highly valued, though not required
  • •Experience with regulatory submissions and standards, including Pinnacle 21, define.xml, and reviewer's guides
  • •Experience working remotely and comfortable with virtual collaboration tools
  • •Excellent written and verbal communication skills, and ability to explain technical concepts to non‑programmers and cross‑functional stakeholders
  • •Strong interpersonal and teamwork skills, with the ability to work independently and prioritize across multiple projects
  • •High attention to detail and focus on quality, reproducibility, and traceability in all deliverables
  • •Demonstrated ability to follow SOPs, adhere to project timelines, and contribute to continuous improvement of programming processes
  • •Proactive problem‑solver and critical thinker, willing to adapt and thrive in a fast‑paced CRO environment
  • •Capable of managing multiple tasks and priorities in a dynamic environment with shifting timelines and evolving sponsor needs
  • •Independent decision‑making ability on complex programming and data‑related decisions
  • •Anticipate analytical needs, understand downstream impacts of programming decisions, and proactively identify gaps in data and specifications
  • •Comfortable working across functional teams (clinical, data management, biostatistics, medical writing) and shifting quickly between strategic and tactical tasks
  • •Demonstrate flexibility, adaptability, initiative, and the ability to troubleshoot efficiently in a collaborative team setting
  • •14 more items(s)

Responsibilities

  • •Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs
  • •Program and QC tables, listings, and figures (TLFs) for interim and final clinical study reports, regulatory submissions, and client deliverables
  • •Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis‑ready datasets and outputs
  • •Act as primary programming contact for assigned studies, collaborating closely with statisticians, data managers, and medical writers in a fully remote, fast‑paced environment
  • •Conduct independent QC and peer review of programming deliverables to ensure accuracy, compliance, and reproducibility of results
  • •Develop and maintain study‑specific programming specifications, documentation, and macros to streamline programming efficiency
  • •Support regulatory submission readiness, including define.xml, reviewer's guides, and response to agency questions
  • •Proactively identify and resolve data or programming issues that may impact timelines or analysis accuracy
  • •Mentor and support junior programmers, fostering quality, consistency, and CDISC best practices across projects
  • •Contribute to process improvement initiatives and template development for a growing statistical programming team
  • •7 more items(s)
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