Principal Statistical R/r-shiny Programmer

1 week ago

Remote, India Parexel Full time

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
  • Glassdoor Reviews and Company Rating

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
  • Detailoriented
  • Analytical

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.
-
Variety: Opportunity to work on a wide range of therapeutic areas and medical devices.

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 startup activities, creation of global programs, tracking spreadsheets, and other required documentation.
  • Review statistical analysis plans and mockshells.
  • Review database setup 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 firsttime 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.
  • Proactive
ly participate in and/or lead process/quality improvement initiatives.

  • Provide consultancy to internal and ex

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