Key Responsibilities
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.
Required Skills
Bachelor's degree in statistics, biostatistics, CS, mathematics, or life sciences.
Minimum 8 years of programming experience in clinical research.
Robust analytical programming proficiency.
In-depth understanding of CDISC and relational databases.
Experience with MS Office, XML, and Pinnacle 21.
Expertise in upstream data handling (eDC, SDTM).
Experience producing ADaM datasets, Define.xml, and submission deliverables.
Knowledge of regulatory standards, clinical tests, and terminology.
Robust team collaboration skills.
Preferred
10+ years of clinical/statistical programming experience.
Experience supporting regulatory filings (NDA/BLA/MAA).
Experience with R and Linux OS.