Principal Statistical (R) Programmer

About This Role

This role involves developing and validating custom programming code, specifically using R, to generate statistical summaries, data listings, and graphs for clinical trials within a biopharmaceutical setting. The Principal Statistical Programmer will also lead programming activities, mentor junior staff, and ensure adherence to industry standards and regulatory guidelines.

Responsibilities

• Develop custom programming code using R or other software to generate summary tables, data listings, graphs, and derived datasets, ensuring outputs meet quality standards and project requirements
• Perform validation programming and collaborate with biostatisticians and project teams to resolve discrepancies
• Keep project team members informed of programming progress and issues
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH)
• Maintain well-organized, complete, and up-to-date project documentation, testing, and QC documents
• Manage scheduling and time constraints across multiple projects, adapting to timeline and priority changes
• Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
• Act as the lead statistical programmer, directing programming activities of other personnel and monitoring progress
• Review project documentation such as Statistical Analysis Plan, mock shells, programming specifications, and annotated CRFs, providing feedback to reduce inefficiencies
• Mentor programming personnel through training courses, materials, work review, and guidance for new associates

Requirements

• Eligibility to work within North America without Sponsorship
• Extensive programming experience in SAS and R or other required software
• Previous Industry Experience within R
• Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
• Experience in mentoring others in clinical trial process and CDISC Standards
• Excellent written and verbal communication skills
• Ability to read, write, speak and understand English

Qualifications

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience
• Extensive programming experience in SAS and R or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.

Nice to Have

• Experience in submissions to a regulatory agency

Skills

* Required skills

Benefits