Principal Statistical Programmer

Overview Principal Statistical Programmer 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. One Team, One Purpose. CONNECT WITH US! Find us on LinkedIn:/the-emmes-group/ Visit our website:https://www.theemmesgroup.com/