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Principal Statistical Programmer with SAS experience, Lithuania

Lithuania, Remote 求人ID R0000021743 Category Statistical Programming
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About this Role

The role is based in Lithuania (home based, office based in Vilnius or hybrid)

Picture Yourself At Parexel:

The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Principal 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 Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

What You'll Do At Parexel:

  • Project Management/Statistical Programming Lead role on projects.

  • Input into and negotiate statistical programming timelines.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

Role requirements:

  • MSc/PhD degree in statistics, econometrics, mathematics, informatics or a related field or equivalent professional experience.

  • Proven experience in Clinical Research.

  • Competent in written and oral English.

  • Ability to successfully lead and mentor a global team a statistical programming environment.

  • Strong project management skills.

  • Excellent analytical and communication skills.

  • Advanced knowledge of SAS programming techniques.

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

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

  • 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.

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program.

We offer a friendly and supportive working atmosphere; we cooperate within projects, help each other, and achieve results as a one team.

Parexel has a fully flexible work arrangement - you can be fully home based. But if you live close to our office and you want to use it, great, you are always welcome, and we will keep the desk ready for you!

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