Principal Statistical Programmer (SDTM)

Overview

Acts as the lead statistical programmer on clinical trial projects, developing and validating SAS programming for SDTM and related outputs while directing other programmers.

What you'll do

• Use SAS 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.
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and work with other programmers, biostatisticians and project team members to resolve discrepancies or findings.
• Keep project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs and relevant regulatory guidelines (e.g. ICH).
• Maintain well organized, complete and up-to-date project documentation, testing and verification/quality control documents and programs, ensuring inspection readiness.
• Manage scheduling and time constraints across multiple projects, set goals based on management priorities, and adapt to timeline or priority changes by reorganizing daily workload.
• Develop specifications for datasets and outputs of any complexity according to statistical and sponsor requirements.
• Anticipate and address potential programming issues and accurately define all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepare for internal meetings, contribute ideas, and conduct effective internal meetings, including distributing information in advance, distributing minutes and following action items to completion.
• Negotiate and establish accurate time estimates for study programming activities with internal team members and statistical programming management, and complete activities within the allotted timeframe.
• Act as the lead statistical programmer, directing the programming activities of other programming personnel and monitoring progress on programming deliverables.
• Review project documentation such as the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs and SAS database design, and provide feedback that reduces programming inefficiencies.
• Participate in sponsor meetings, kickoff meetings and bid defense meetings as statistical programming representative, as required by sponsor.
• Contribute to mentoring programming personnel through developing training courses, presenting training materials, reviewing work and providing feedback or guidance.
• Transfer deliverables.
• Perform other work-related duties as assigned.

What you'll need

• 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 or other required software, preferably in a clinical trial environment.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

Details

• Location: IND-Remote.
• Minimal travel may be required.