[Hiring] Statistical Programmer 5 @Employvision

Role Description

• Develop SAS programs for analysis datasets (ADaM/SDTM) and TLF outputs.
• Validate analysis datasets and outputs.
• Support e-submission preparation and review.
• Review key planning documents (SAP, data plans) and assess programming impacts.
• Interact with vendors for standards and file transfers.
• Ensure high-quality GBDS deliverables aligned with regulatory standards.
• Identify efficiency and consistency improvements.
• Lead programming assignments independently.
• Support process improvement initiatives.

Qualifications

• Bachelor's degree in Statistics, Biostatistics, CS, Mathematics, or Life Sciences.
• Minimum 8 years of programming experience in clinical research.
• Strong analytical programming proficiency.
• In-depth understanding of CDISC, relational databases.
• Experience with MS Office, XML, Pinnacle 21.
• Expertise in upstream data handling (eDC, SDTM).
• Experience producing ADaM datasets, Define.xml, submission deliverables.
• Knowledge of regulatory standards, clinical tests, and terminology.
• Strong team collaboration skills.

Requirements

• 10+ years of clinical/statistical programming experience (preferred).
• Experience supporting regulatory filings (NDA/BLA/MAA) (preferred).
• Experience with R and Linux OS (preferred).