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.
• 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 SAS and processes/procedures within other PAREXEL functional areas.
• Provide relevant training and mentorship to staff and project teams.

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.
• Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Skills

• Excellent analytical skills.
• Proficiency in SAS.
• Extensive knowledge and understanding of the programming and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• 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 a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Business/operational skills that include customer focus, commitment to quality management, and problem solving.
• Demonstrate commitment to refine quality processes.
• Good presentation skills.
• Good business awareness/business development skills (including financial awareness).

Knowledge And Experience

• Competent in written and oral English.
• Excellent communication skills.

Education

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