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
Bachelors degree in Statistics, Biostatistics, CS, Mathematics, or Life Sciences.
Minimum 8 years of programming experience in clinical research.
Solid 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.
Solid team collaboration skills.
Preferred
8+ years of clinical/statistical programming experience.
Experience supporting regulatory filings (NDA/BLA/MAA).
Experience with R and Linux OS.