Principal Statistical Programmer

Responsibilities:Manage programming activities on project or study level, including managing CROs to ensure deliverables are accurate and compliant.ct as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, eSUB packages, and documenting production and validation programs.pply programming skills to support statistical analysis, clinical reporting, regulatory submissions, Ad-Hoc/post-Hoc requests, and scientific publications.Work with Biostatistics and other functions for the development and maintenance of the data review and reporting tools, e.g., aCRF, SAP, and mock review, and any other statistical applications as appropriate.Work with CRO counterpart on project timeline management; oversee and provide input on statistical programming activities, ensure timely and quality delivery.Requirements:

Principal Statistical Programmer requires a minimum of 3 years of statistical programming. An equivalent combination of education and experience may be considered.Hands-on experience and in-depth knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, Pinnacle 21 reports, and define xml.Excellent knowledge of SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT; advanced SAS programming ability to implement standard statistical analyses; experience in developing SAS macros to standardize the workflow and internal processes.Experience in CNS, pediatric rare disease area preferred.Experience in CRO management.Strong communication, leadership and interpersonal skills required.

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