Statistical Programmer I (UK, Sheffield)
Parexel International Corporation
Sheffield, England, United Kingdom
The Statistical Programmer I works with 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.
* 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 WSOP's/Guidelines to ensure traceability and regulatory compliance.
* Ensure compliance with WSOP's/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 WSOP's/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.
* First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.
* Competent in written English.
* Good communication skills.