Principal Statistical Programmer

Principal Statistical Programmer - Remote Europe OR LATAM

Be Part of One Team, One Purpose.

At Emmes Group , we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence , we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience . Through our two business units—Emmes, a full-service CRO , and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people —people who are passionate, purpose-driven, and ready to make an impact . At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact . Our culture is built on integrity, collaboration, and innovation , ensuring that every challenge is met with perseverance and accountability.

The Principal Statistical Programmer is a senior-level contributor responsible for designing, developing, validating, and maintaining statistical programming deliverables to support clinical trials and regulatory submissions. This individual serves as a technical expert on study and project teams, providing leadership in the application of statistical programming standards and regulatory guidance (e.g., CDISC, ICH, FDA).

Responsibilities

• Technical Programming Leadership
• Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation.
• Program complex Tables, Listings, and Figures (TLFs) for study reports, publications, and submissions.
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code.
• Project & Study Support
• Serve as lead programmer on multiple studies and/or projects, coordinating efforts across internal teams and CROs.
• Provide technical oversight and mentoring to junior programmers and contractors.
• Collaborate closely with Biostatistics, Data Management, and Clinical teams to deliver timely and accurate outputs.
• Standards & Compliance
• Ensure programming deliverables comply with industry standards (CDISC, FDA, EMA) and internal SOPs.
• Contribute to the development and implementation of programming standards and reusable code libraries.
• Participate in quality control, peer review, and validation of programming deliverables.
• Submission & Regulatory Support
• Prepare and review submission ready datasets, define.xml files, and reviewer guides for regulatory authorities (e.g., FDA, EMA).
• Support integrated summaries of safety (ISS) and efficacy (ISE) analyses for NDA/BLA/MAA submissions.
• Use tools such as Pinnacle 21, OpenCDISC, and define.xml generators to ensure submission compliance.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelor's Degree Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field. Required or
• 7-9 years in statistical programming within the pharmaceutical, biotech, or CRO industry. Required
• Expert level proficiency in SAS Base, SAS Macro, and SAS SQL. High
• In depth experience with CDISC SDTM and ADaM standards. High
• Proven track record of supporting clinical trial reporting and regulatory submissions. High
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA and EMA regulatory expectations. High
• Excellent problem solving skills and attention to detail. High
• Strong communication and collaboration skills. High

If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact , join us and be part of something bigger.

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