Your impact and responsibilities…
-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.
-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.
Statistical Programming for Assigned Projects
-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.
-Maintain and expand local and international regulatory knowledge within the clinical industry.
-Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
-Provide relevant training and mentorship to staff and project teams.
-Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
-Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
-Proactively participate in and/or lead process/quality improvement initiatives.
-Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
-Represent Parexel at sponsor marketing and technical meetings.
-Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).