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

求人ID 27739BR ロケーション 中国 仕事内容
Job Purpose:
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an
internal subject matter expert in specific areas providing technical support and expert advice, and works
independently to support various programing activities related to the analysis and reporting of clinical
study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role on
projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional
areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource
allocation, and productivity in relation to budgets.
Key Accountabilities:
Project Management
Ability to fill Statistical Programming Lead role on projects
o Input into and negotiate statistical programming timelines.
Ensure that timelines are adhered to.
o Coordinate and lead a statistical programming team to
successful completion of a study within given timelines and
budget.
o 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).

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, 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.
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