Description
Essential duties and responsibilities Include but are not limited to the following:-
Lead statistical programming deliverables for single or multiple studies. - Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents.
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Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications. -
Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADAM datasets. -
Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities. - Provide support to and mentor junior programmers and contractors
Requirements:
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8+ years clinical research and development statistical programming experience. -
Computer programming using SAS. -
Understanding of computer operating systems, word processors, document applications. - Drug development process.
**Preferred: Extensive hands-on experience in CDSIC standards and data sets (SDTM, ADAM). Experience in Oncology Trials. Experience in FDA/EMEA trial submissions. Drug Development (pre-early, late and/or observational) in related industries or academic research.**
Education:
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Bachelors or Master's degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject.