Senior/Principal Programmer

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.