• Contract
  • Remote

SimulStat

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Remote, 6-month contract with potential to extend. Client-focused; directly supporting pharmaceutical company.

As a Senior Programmer, you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. This will provide you with the perfect opportunity to expand on your experiences and develop new skills in a stimulating work environment.

Key responsibilities include (not an exhaustive list of duties):

  • 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
  • Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards
  • Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
  • Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both the company and sponsors
  • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities

Skills:

  • Proficiency in SAS
  • Knowledge of the programming and reporting process
  • Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
  • Strong leadership skills
  • Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
  • Excellent analytical skills
  • Effective time management in order to meet daily metrics or team objectives

Education:

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

Language Skills:

  • Excellent communication skills both verbal and written

Required skills and experience:

  • 5 plus years proficiency in SAS programming
  • 2+ years of ADaM, CDISC or SDTM
  • HARP experience
  • Lead experience in a Pharma setting
  • Attention to detail, ability to be self-driven and solid organization skills
  • Excellent communication skills (verbal and written)

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