Statistical Programmer
Statistical Programmer
trigent software - professional services- Posted 14 hours ago
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Job Description
Statistical Programmer
Experience
- 4+ years
Role Summary
Responsible for end-to-end statistical programming activities for clinical studies, from specification creation through regulatory submissions, ensuring high-quality and compliant deliverables.
Key Responsibilities
- Develop and validate SDTM, ADaM, and TLFs.
- Create and review programming specifications.
- Support regulatory submissions and ensure CDISC compliance.
- Perform QC and maintain programming standards.
- Collaborate with cross-functional teams and support study deliverables.
- Contribute to process improvements and mentoring activities.
Required Skills
- Strong SAS programming expertise
- Hands-on experience with SDTM, ADaM, TLFs, and regulatory submissions.
- Good understanding of CDISC standards and clinical trial processes.
More Info
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About Company
Skills:
markdown , cdisc standards , Java, Unix, SAS, Sdtm, Git, Linux, Python, Shiny, Define.xml, Medical Terminology, ADAM, R, FDA ICH regulation, clinical trial methodologies
Skills:
cdisc standards , Statistical Analysis, R Programming, Sas Programming, Clinical data programming, ICH standards
Skills:
Base Sas, Advanced Sas, Proc Sql, Python, SAS Macro Programming, R, Utility development, Reporting process automation
Skills:
Sas Programming, Sdtm, case report form design, ad hoc analyses, programming specifications, department SOPs, cdisc, business development, statistical programming, ADAM
Skills:
Pinnacle 21 (P21) for CDISC compliance checks and data validation, Statistical analysis plans (SAPs), Sas Programming, R Programming, statistical programming, Production-quality programming code, Programming specifications, Clinical trial analysis and reporting