Senior Statistical Programmer/Analyst III
ClinChoiceArmenia
Posted August 21, 2025
Full Time
About the Company
ClinChoice is a leading global full-service CRO with three decades of experience in pharmaceutical, biotechnology, medical device, and consumer health sectors. Specializing in clinical development, post-marketing and real-world evidence, quality and compliance, and technology solutions, ClinChoice offers comprehensive support worldwide with its deep regulatory expertise, robust pharmacovigilance, and project management capabilities.
Job Description
ClinChoice is seeking a Senior Statistical Programmer/Analyst III to join their in-house team as a permanent, full-time position. The role involves annotating case reports, developing SDTM specifications, generating ADaM datasets, and contributing to regulatory submissions. The company is a global clinical development CRO focused on fostering a collaborative and rewarding work environment.
Requirements
- Annotate case report form following FDA/CDISC guidelines
- Develop SDTM specifications and generate SDTM datasets using SAS
- Develop ADaM, specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan
- Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
- Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
- Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision.
Benefits
- Flexible Working Hours
- Health Insurance
- Employee Satisfaction Survey