The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical
support and expert advice to internal and external sponsors, and works independently to support various
programing activities related to the analysis and reporting of clinical study data. In addition, the Principal
Statistical Programmer can fill the Statistical Programming Lead role on projects and liaise with sponsors,
Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the
Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in
relation to budgets.
Ability to fill Statistical Programming Lead role on projects
o Input into and negotiate statistical programming timelines.
Ensure that timelines are adhered to.
o Coordinate and lead a statistical programming team to
successful completion of a study within given timelines and
budget.
o 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 inthe conduct of their daily work.

Qualifications

• Excellent analytical skills.
• Advanced knowledge of SAS programming techniques.
• Extensive knowledge and understanding of the programming and reporting process.
• Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international
regulations such as 21 CFR Part 11.
• Knowledge of the efficacy endpoints and analysis techniques specific to the disease being
treated.
• Ability to learn new systems and function in an evolving technical environment.
• Strong project management skills.
• Strong organizational skills, ability to manage competing priorities, and flexibility to change.
• Attention to detail.
• Ability to successfully lead and mentor a global team.
• Work effectively in a quality-focused environment.
• Excellent time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Strong business/operational skills that include customer focus, commitment to quality
management, and problem solving.
• Demonstrate commitment to refine quality processes.
• Good presentation skills.
• Ability to negotiate and influence in order to achieve results.
• Good business awareness/business development skills (including financial awareness).
• Client-focused approach to work.
• Good negotiation skills.