Principal Stat Programmer

Principal Stat Programmer

Roles and Responsibilities

• Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets.
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and collaborate with project teams to resolve discrepancies.
• Manage scheduling and time constraints across multiple projects, setting goals and adapting to changes in priorities.
• Develop specifications for datasets and outputs of any complexity.
• Act as the lead statistical programmer, directing the activities of other programming personnel and monitoring their progress.
• Review project documentation, such as the Statistical Analysis Plan, mock shells, and programming specifications, providing feedback to reduce inefficiencies.
• Participate in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative.
• Contribute to the mentoring of programming personnel by developing training courses and providing guidance to new associates.
• Serve as a technical expert resource for complex programming questions, with a good working knowledge of clinical drug development, industry standards, and electronic submission requirements.
• Contribute technical expertise to the development of programming tools and macros for standardization and efficiency.
• Act as a subject matter expert for CDISC and other industry and regulatory requirements, providing guidance and performing compliance reviews of project deliverables.

Skills Required

• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
• Knowledge and experience in the use of CDISC Standards for regulatory agency requirements.
• Experience with submissions to a regulatory agency is preferred.
• Experience in mentoring others in clinical trial processes and CDISC Standards.
• Excellent written and verbal communication skills.
• Ability to manage concurrent programming deliverables and negotiate timelines.
• Experience with applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
• Strong ability to maintain organized, complete, and up-to-date project documentation.