Senior / Principal Statistical Programmer, Clinical Development Data Services

Role Overview

• Independently lead programming activities of moderate to high complexity while ensuring quality, accuracy, and adherence to timelines.
• Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards, study specifications, and regulatory requirements.
• Program, validate, and deliver Tables, Listings, and Figures (TLFs) for clinical study reports, interim analyses, and regulatory submissions.
• Perform quality control (QC) reviews and ensure traceability, reproducibility, and compliance of programming deliverables.
• Contribute to the development of dataset specifications, define.xml files, reviewer guides, and other submission documentation.
• Support preparation and delivery of electronic submission packages for global regulatory agencies, including FDA and EMA.
• Collaborate with Biostatisticians on implementation of Statistical Analysis Plans (SAPs) and interpretation of programming requirements.
• Support data review, data cleaning, discrepancy management, and database lock activities throughout the study lifecycle.
• Work closely with Data Management and external vendors to ensure consistency of standards and data quality.
• Ensure compliance with SOPs, GxP requirements, CDISC standards, and industry best practices.
• Drive adoption of innovative programming approaches and AI-assisted workflows to improve efficiency, quality, and scalability of clinical trial deliverables.
• Contribute to programming standards, macros, and process improvements that enhance efficiency and quality.
• Provide technical guidance and mentoring to junior programmers when appropriate.

Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative field.
• 5+ years of statistical programming experience within the pharmaceutical or biotechnology industry, oncology preferred.
• Strong programming skills in SAS (base, macro, SQL, STAT, GRAPH); knowledge of R/Python is an advantage.
• Solid understanding of CDISC standards, controlled terminology, define.xml, and submission requirements.
• Hands-on experience preparing regulatory submission packages (define.xml, Pinnacle 21, reviewer guides) for FDA/EMA.
• Demonstrated interest in applying automation and AI-enabled solutions to improve programming efficiency and data quality.
• Strong attention to detail with excellent analytical, problem-solving, and documentation skills.

Tech Stack

• Python
• SQL

Benefits

• Continuous learning opportunities
• Impact millions of lives
• Strong emphasis on teamwork
• Low hierarchies
• A culture where every voice is heard