• Deliver best value and high quality service.
• Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:
• 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.
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
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• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
• Be trained in sponsor WSOP’s and disseminate knowledge to project team members as appropriate.
• Proactively participate in and/or lead process/quality improvement initiatives.
• Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
• Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, SQL, and other programming language usage and processes within the GRO, biostatistics, and medical arenas.
• Maintain and expand local and international regulatory knowledge within the clinical industry.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsors.
• Provide broad support, including advice on new technologies and industry technical standards (e.g. EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes.
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
• Provide consultancy to internal and external sponsors with regard to statistical programming tasks. In addition, maintain visibility to these sponsors to ensure expectations are being met and that requirements are accurately distributed to the appropriate stakeholders.
• Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy).
• Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
• Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
• Represent Statistical Programming on cross-functional technical initiatives.
• Contribute to the development and delivery of internal and external technical training seminars and courses.
• Mentor and train other members of the department.
• Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
• Develop mapping specifications for data exports in accordance with applicable standards.Qualifications
• Proficiency in SAS.
• Knowledge of the programming and reporting process.
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
• Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement.
• Demonstrate ability to learn new systems and function in an evolving technical environment
• Strong leadership ability.
• Ability to successfully work together with a ( virtual) team (including international teams as required) as well as independently.
• Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
• Attention to detail.
• Excellent analytical skills.
• Good presentation skills.
• Tenacity to work in an innovative environment.
• Ability to negotiate and influence in order to achieve results.
• Business/Operational skills that include customer focus, commitment to quality management and problem solving.
• Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Work effectively in a quality-focused environment.
• Demonstrate commitment to refine quality processes.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Competent in written and oral English.
• Excellent communication skills.
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