Statistical Programmer I
Parexel
St Petersburg, Saint Petersburg, Russia
18 дней назад

Essential FunctionThe Statistical Programmer I works with close supervision to support various programming activities related to the analysis and reporting of clinical study data.

General areas of responsibility also include : import / export programming specification development, test data creation and test data entry, import / export programming functional testing, as well as mapping specifications to support relevant data standards.

Key Accountabilities* Deliver best value and high quality service.* Check own work in an ongoing way to ensure first-time quality.

  • Maintain all supporting documentation for studies in accordance with WSOPs / Guidelines to ensure traceability and regulatory compliance.
  • Ensure compliance with WSOPs / Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal / external audits and regulatory inspections as required.
  • Use efficient programming techniques to produce low-medium complexity derived datasets, tables, figures and data listings.
  • Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
  • Develop mapping specification for data exports in accordance with applicable standards.QualificationsSkills
  • Experience in SAS.* Knowledge of the programming and reporting process within the Statistical Programming Department.* 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.

  • Demonstrate ability to learn new systems and function in an evolving technical environment.* Attention to detail.* Ability to successfully work together with a ( virtual ) team (including international teams as required) as well as independently.
  • Work effectively in a quality-focused environment.* Effective time management in order to meet daily metrics or team objectives.
  • Show commitment to and perform consistently high quality work. Minimum Work Experience* Relevant work experience recommended.Education
  • First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.Language Skills
  • Competent in written English.* Good communication skills.
  • Essential Function Key Accountabilities

    Qualifications

    Skills Education Language Skills

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