Statistical Programming (United States)

Key Responsibilities: End-to-End Programming: Conduct independent validation and quality checks of statistical programming deliverables, including SDTM, ADaM, and TFLs from Biometrics Service Providers; independently develop customized analysis datasets. Reporting Deliverables: Program and validate complex TFLs for ad-hoc and post-hoc analyses to support emerging clinical questions, publications, internal decision-making, and regulatory submissions. Regulatory Compliance: Ensure all deliverables meet CDISC standards (SDTMIG, ADaMIG) and comply with regulatory (e.g., FDA/EMA) guidelines. Communication: Collaborate closely with study lead programmers and statisticians to deliver results in a timely and accurate manner. Submission Documentation: Review technical documentation including Define.xml, Reviewer’s Guides (cSDRG/ADRG), and analysis metadata.

Education: Master’s degree in Biostatistics, Statistics, or a related field

Experience: Minimum of 3 years of hands-on statistical programming experience within the Pharmaceutical or CRO industry; Independent validation experience of datasets and statistical deliverables. SAS Master: Proficiency in SAS (Base, Stat, Macro, Graph) with a proven track record in a clinical environment. Standardization: Comprehensive knowledge of CDISC implementation and the ability to interpret protocol and complex statistical Analysis Plans (SAPs).Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA).