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