Senior Statistical Programmer/Analyst II
ClinChoiceArmenia
Posted August 27, 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 a global full-service CRO seeking a dynamic Senior Statistical Programmer/Analyst II to join their team. This role involves annotating case reports, developing SDTM/ADaM specifications, developing data for clinical trials, and providing guidance to statisticians for statistical analysis. The role requires strong analytical, communication, and problem-solving skills, with experience in regulatory requirements.
Requirements
- Annotate case report form (FDA/CDISC or sponsor guidelines)
- Develop SDTM/ADaM specifications and generate datasets using SAS
- Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report
- Create electronic submission package to FDA
- Proficient in analyze information and develop innovative solutions to programming and data analysis challenges
- Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation
- Follow and reinforce regulatory agency requirements
- Serve as a programming team lead
- Provide guidance and mentoring for team members
- Review draft and final production deliverables for project
- Work with global team or sponsors to coordinate project deliverables
- Excellent communication and coordination skills
- Good understanding of clinical drug development process
Benefits
- Flexible Working Hours
- Full performance and development process
- Team events and end of year party
- Employee satisfaction survey