Clinical Trial Programmer/ Senior Statistical Programmer An opportunity for a Clinical Trial Programmer/Statistical Programmer within a clinical research environment has opened up with our company.
The role involves analyzing and reporting clinical trial data, collaborating with trial programmers and statisticians to design datasets, generate reports, and perform statistical analyses for clinical trials.
Responsibilities:
Data Analysis & Reporting: Analyze trial data and generate reports like Tables, Listings, and Figures for statistical analyses.
Trial Documentation & Feedback: Review trial documentation from a statistical programming perspective and provide feedback.
Data Set Design & Metadata: Define and implement analysis datasets, metadata, and perform complex data derivations.
QC & Documentation: Conduct quality control activities, maintain up-to-date documentation for programs, datasets, and other trial-related materials.
Collaboration & Communication: Work closely with trial programmers, statisticians, and clinical trial teams to ensure data analysis aligns with trial goals and standards.
Technical Support & Advice: Provide programming support and advise on best practices to colleagues.
Process Improvement: Contribute to the development of new standards, policies, and procedures for data management and analysis.
Compliance: Ensure compliance with regulatory standards such as ICH-GCP.
Required Qualifications:
Educational Background: A degree in mathematics, informatics, or a related scientific field.
Technical Skills: Strong experience in SAS programming and statistical analysis, with knowledge of SDTM, ADaM, and R (or other programming languages) being an asset.
Experience: At least five years of experience in statistical programming within the pharmaceutical or clinical research sector.
Regulatory Knowledge: Familiarity with international clinical research regulations like ICH-GCP.
Communication Skills: Strong interpersonal and English communication skills, with the ability to work independently and within teams.
This role requires ensuring clinical trial data is analyzed and reported accurately, in compliance with regulatory standards, and is communicated effectively to all relevant stakeholders.
Seniority Level Mid-Senior level
Employment Type Contract
Job Function Quality Assurance and Management
Industries Research Services and Information Services
#J-18808-Ljbffr