Description

You will lead statistical programming solutions for clinical trials, ensuring CDISC compliance and high-quality data outputs.

This role is on-site.

Responsibilities

• Design and write program specifications in consultation with Biostatisticians.
• Develop SAS code to produce CDISC compliant datasets, including ISS, ISE, and pooled datasets.
• Create statistical analysis outputs for final reports, abstracts, posters, manuscripts, and clinical publications.
• Execute QC SAS programs for Datasets, Tables, Listings, and Figures following departmental procedures.
• Generate and review Pinnacle 21 reports, Define.xml, Define.pdf, and Reviewer Guides.

Required Skills

• 5+ years of experience in statistical programming.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Proficiency in Base SAS, SAS/STAT, SAS Graph, and SAS Macro Language.
• In-depth knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Expertise in the drug development process and Study Data Tabulation Model (SDTM).
• Ability to implement programming specifications and estimate project scope.
• Master's degree in Computer Science, Statistics, or a related field; or a Bachelor's degree with equivalent experience.

Preferred Skills

• SAS certification.
• R programming knowledge.

Key Skills

Education

Any Graduate