Overall Summary of the Role:
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.
Key Duties Include:-
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 sup-port, 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, SOP’s/Guidelines, ICH-GCP, and/or other international regulatory requirements.
Essential Skills and Experience Required:-
• 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 treat-ed.
• 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.