Key Accountabilities:

Project Management:

• 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.

• 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:

• Educated to degree level in a relevant discipline and/or equivalent work experience.