Sr. Manager, Statistical Programming

Overview Sr. Manager, Statistical Programming 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 Senior Manager, Statistical Programming is a leadership role responsible for overseeing a team of statistical programmers and managing the planning, execution, and delivery of programming activities across clinical development programs. This individual ensures the quality, timeliness, and regulatory compliance of all statistical programming deliverables, and serves as a strategic partner to cross functional teams including Biostatistics, Data Management, and Clinical Operations. The role requires strong technical expertise in SAS programming, CDISC standards, and regulatory submission experience, as well as demonstrated leadership in managing teams and complex clinical projects. Responsibilities Leadership & Team Management Lead, mentor, and develop a team of statistical programmers, providing guidance on technical and project related matters. Allocate resources and assign projects across studies and programs to meet corporate and clinical timelines. Conduct performance reviews, support career development, and foster a culture of accountability and innovation. Project & Technical Oversight Oversee the development, validation, and documentation of SDTM, ADaM datasets, and TLFs for clinical trials and regulatory submissions. Act as lead programmer for high profile or complex studies, ensuring high quality deliverables. Review and approve programming specifications and outputs, ensuring consistency and accuracy. Strategic & Cross Functional Collaboration Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and external vendors to define data and analysis requirements. Serve as the primary programming point of contact for internal stakeholders and regulatory authorities, as needed. Participate in strategic planning and resource forecasting for clinical programs. Quality, Compliance & Innovation Ensure adherence to internal SOPs, ICH GCP guidelines, CDISC standards (SDTM/ADaM), and regulatory submission requirements (e.g., FDA, EMA). Support regulatory submission activities including preparation of define.xml, reviewer's guides, and integrated summaries (ISS/ISE). Drive process improvement and contribute to the development of global programming standards and automation tools. Performs other duties as assigned Complies with all policies and standards Qualifications Bachelor's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Required or Master's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Preferred 10+ years in statistical programming in the pharmaceutical, biotech, or CRO industry. Required 1-3 years in a management or senior team lead role. Required Expert proficiency in SAS (Base, Macro, SQL), and strong knowledge of CDISC (SDTM/ADaM). High Proven track record in supporting regulatory submissions (e.g., NDA, BLA, MAA). High Strong understanding of clinical development processes and regulatory requirements. High Excellent organizational, leadership, and communication 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/