统计编程师（中国）Statistical Programmer I/II/Senior/Principal

Job Description:

Job Purpose:The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as aninternal subject matter expert in specific areas providing technical support and expert advice, and worksindependently to support various programing activities related to the analysis and reporting of clinicalstudy data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role onprojects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functionalareas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resourceallocation, and productivity in relation to budgets.

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 tosuccessful completion of a study within given timelines andbudget.
• Monitor project resourcing, project budgets, and identifychanges 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 tostatistical programming issues.
• Assist project teams in the resolution of problems encountered inthe 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 supportingdocuments and submission documentation.
• Ensure quality control (QC) is performed on all process andtechnical activities related to derived dataset, table, data listing, andfigure programming in accordance with corporate quality standards,
• SOPs/Guidelines, ICH-GCP, and/or other international regulatoryrequirements.

Training

• Maintain and expand local and international regulatory knowledge within the clinical industry, functional areas.
• Provide relevant training and mentorship to staff and project teams.

General

• Maintain all supporting documentation for studies in accordancewith SOPs/Guidelines to ensure traceability and regulatorycompliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any otherapplicable local and international regulations, and participate ininternal/external audits and regulatory inspections as required.
• Proactively participate in and/or lead process/quality improvementinitiatives.
• Provide consultancy to internal and external sponsors with regardto statistical programming tasks.
• Represent Parexel at sponsor marketing and technical meetings.
• Understand regulatory requirements concerning industry technicalstandards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
• Develop knowledge of SAS and processes/procedures within otherParexel functional areas

Job Qualifications:

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 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, andproblem 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.