We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers.
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.
