Principal Statistical Programmer (Remote Europe or LATAM)

About the role

Emmes Group, a clinical research organization with over 47 years of experience in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases and neuroscience, is hiring a Principal Statistical Programmer. The role is remote and open to candidates based in Europe or Latin America. The Principal Statistical Programmer designs, develops, validates and maintains statistical programming deliverables for clinical trials and regulatory submissions, acting as a technical expert and leader on study and project teams.

Key responsibilities

• Lead the development, validation and maintenance of SDTM and ADaM datasets and their documentation
• Program Tables, Listings and Figures (TLFs) for study reports, publications and submissions
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code
• Serve as lead programmer on multiple studies and projects, coordinating with internal teams and CROs
• Mentor junior programmers and contractors and work with Biostatistics, Data Management and Clinical teams
• Ensure deliverables comply with CDISC, FDA, EMA and internal SOPs, and contribute to standards and reusable code libraries
• Take part in quality control, peer review and validation
• Prepare and review submission-ready datasets, define.xml files and reviewer guides for regulators, and support ISS and ISE analyses for NDA/BLA/MAA submissions using tools such as Pinnacle 21, OpenCDISC and define.xml generators

Required profile

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences or a related field
• 7-9 years of statistical programming experience in the pharmaceutical, biotech or CRO industry
• Proven track record supporting clinical trial reporting and regulatory submissions
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA and EMA expectations
• Excellent problem-solving skills, attention to detail, and strong communication and collaboration skills

Required skills

• Expert-level SAS Base, SAS Macro and SAS SQL
• In-depth experience with CDISC SDTM and ADaM standards