Key Accountabilities:
Project Management:
-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.
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.
Training:
Maintain and expand local and international regulatory knowledge within the clinical industry.
Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other PAREXEL functional areas.
Provide relevant training and mentorship to staff and project teams.
Lead knowledge sharing forums and proactively support the development of the wider department.
General:
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.
Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity.
Represent Statistical Programming on cross-functional technical initiatives.
Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
Skills:
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.
Knowledge and Experience:
Competent in written and oral English.
Excellent communication skills.
Proven record of successfully leading teams in a statistical programming environment.
Education:
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