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Senior/Principal Statistical Programmer

Employer
Parexel - USA
Location
United States
Salary
Competitive
Start date
25 Sep 2022
Closing date
12 Oct 2022

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Job Details

Be part of our empowered Parexel Statistical Programming team today!

As aPrincipalor SeniorProgrammeryou will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. Parexel 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 Parexel 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
  • Lead experience in a Pharma setting
  • Attention to detail, ability to be self-driven and solid organization skills
  • Excellent communication skills (verbal and written)

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

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