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Principal Statistical Programmer

2 months ago

HybridRemote, UK, United Kingdom myGwork Full time

This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.

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.

  • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.

  • 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 areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other PAREXEL functional areas.

  • Provide relevant training and mentorship to staff and project teams.

  • Lead knowledge sharing forums and proactively support the development of the wider department.

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.

  • Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity.

  • Represent Statistical Programming on cross-functional technical initiatives.

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

Skills:

  • Excellent analytical skills.

  • Advanced knowledge of SAS programming techniques.

  • Extensive knowledge and understanding of the programming and reporting process.

  • Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.

  • Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated.

  • 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 and mentor a global team.

  • Work effectively in a quality-focused environment.

  • Excellent time management in order to meet daily metrics or team objectives.

  • Show commitment to and perform consistently high quality work.

  • Strong business/operational skills that include customer focus, commitment to quality management, and problem solving.

  • Demonstrate commitment to refine quality processes.

  • Good presentation skills.

  • Ability to negotiate and influence in order to achieve results.

  • Good business awareness/business development skills (including financial awareness).

  • Client-focused approach to work.

  • Good negotiation skills.

Knowledge and Experience:

  • Competent in written and oral English.

  • Excellent communication skills.

  • Proven record of successfully leading teams in a statistical programming environment.


Education:

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


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