Principal Statistical Programmer, North America

Role Overview

• Uses R, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications
• Works to ensure that outputs meet quality standards and project requirements
• Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings
• Keeps project team members informed of programming progress and issues requiring their attention
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
• Anticipates and addresses potential programming issues
• Conducts effective internal meetings (appropriate in format, frequency and attendance)
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business
• Accountable for on-time delivery across concurrent programming deliverables
• Acts as the lead statistical programmer
• Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements

Requirements

• Previous Industry Experience within R is required
• Must be eligible to work within North America without Sponsorship
• Undergraduate degree, preferably in a scientific or statistical discipline
• Extensive programming experience in SAS and R or other required software, preferably in a clinical trial environment
• Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
• Experience in submissions to a regulatory agency preferred
• 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.

Benefits

• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time