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
Skills Education Language Skills