Principal Statistical Programmer

Ability to fill Statistical Programming Lead role on projects

Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.

Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.

Monitor project resourcing, project budgets, and identify changes in scope.

Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

Review statistical analysis plans and mock-shells.

Review database set-up specifications.

Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.

Interact with sponsors and internal stakeholders with regard to statistical programming issues.

Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Deliver best value and high quality service.

Check own work in an ongoing way to ensure first-time quality.

Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.

Produce/QC dataset specifications and other process supporting documents and submission documentation.

Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.