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Job Title
Senior Statistical Programmer
Company
PAREXEL International Corporation
Job Description
Parexel.com
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Senior Statistical Programmer
China, Remote
Date posted
12/22/2022
Job ID
R0000006660
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Overview
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Responsibilities
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As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound.
You will become a part of a team with an inherent breadth of knowledge and expertise in small, single center Investigator studies to multi-site, multi-national trials in Phases I to IV of clinical development, as well as observational studies. From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers will employ industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects.
Parexel develops and delivers cost effective, high-quality training programs for those employees that are directly involved with sponsor functional partnerships to ensure that our statistical programmers can quickly step in to make significant contributions to the success of a study. In addition, you will receive the opportunity to shape your development through quarterly conversations with your manager. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
Full Time
Travel: Minimal
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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
Team player
Tech-Savvy
Communicator
Proactive
Detail-oriented
Analytical
"I have learned a great deal and developed my expertise. The management team here is open and honest and it is refreshing to be treated with a high degree of trust and flexibility. I have been fortunate to work on a wide variety of projects and partnerships and the work is always interesting."
Richard – Principal Statistical Programmer
Rewards
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Development
Opportunity to learn and grow through a performance and development goal-setting program.
Collaboration
Work with industry leaders and subject matter experts.
Variety
Opportunity to work on a wide range of therapeutic areas and medical devices.
Responsibilities
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.
#LI-REMOTE
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