Senior/Principal Programmer Overview • The Senior/Principal Programmer role offers an opportunity to lead statistical programming projects within a dynamic clinical research environment. • Collaborate with global teams to develop and maintain clinical trial data and statistical reporting standards. • Contribute to innovative oncology research, supporting impactful clinical trials worldwide. • Provide mentorship and technical guidance to project team members, fostering professional growth and excellence. • Engage in regulatory submissions, ensuring compliance with industry standards and requirements. • Join a globally recognized organization with over 20 years of experience in clinical research. • Be part of a team with expertise across more than 30 therapeutic areas, including oncology. • Work remotely while contributing to cutting-edge clinical research projects. Senior/Principal Programmer Key Responsibilities & Duties • Lead statistical programming project teams, overseeing timelines, task assignments, and deliverable quality. • Develop and maintain clinical trial data and statistical reporting standards aligned with industry requirements. • Perform primary statistical programming and validation for clinical studies and regulatory submissions. • Create and review SDTM mapping specifications, annotated CRFs, and ADaM data specifications. • Prepare statistical programming documentation for regulatory submissions and client deliverables. • Provide mentorship and technical supervision to programming team members on assigned projects. • Participate in the development of SOPs, guidelines, and best practices for statistical programming. • Represent the organization in interactions with sponsor companies regarding programming and reporting requirements. • Plan and execute archiving of statistical programming information upon project completion. Senior/Principal Programmer Job Requirements • Master's degree in Computer Science or related field with 10 years of experience, or PhD with 9 years of experience. • In-depth knowledge of clinical trial data management, statistical programming, and regulatory requirements. • Proficiency in SAS programming and statistical analysis for clinical trials. • Experience in developing and maintaining data standards and reporting conventions. • Strong leadership skills to manage project teams and ensure quality deliverables. • Ability to prepare documentation for regulatory submissions and client interactions. • Knowledge of ICH guidelines and FDA submission requirements. • Proven ability to mentor and guide team members in statistical programming tasks. • Commitment to maintaining high standards in data, programming, and reporting practices.