CORE JOB FUNCTIONS: Provide programming input to CRF, SAP, analysis - file specifications, and tables, figures, and listings (TFLs) shells. Write SAS programs to generate derived analysisdatasets, perform analysis, and TFLs. Perform ad hoc flexible and rapid programmingarising from questions generated from planned analyses and results. Ensure consistency and adherence to standardswithin their therapeutic area Provide programming support for the preparationof integrated reports, submissions and post-submission activities. Oversee the services provided by CROs. Contribute to the creation, maintenance, andvalidation of standards for programming tools, outputs and macros. Provide training on departmental SOPs/WPs andstandard programs Contribute to the creation of naming conventionsand standards for the programming environment. Participate in industry wide technicaldiscussions. KNOWLEDGE, SKILLS & ABILITIES (KSA\'s): Bachelorâ??s degree in life science, statistics,mathematics, computer science, or related field is required Masterâ??s degree is preferred. 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with aBachelorâ??s degree; or 5 plus years experience with a MS/MA degree. Experience in Oncology, Hematology Cancer (i.e.CLL) and Medical Affair Projects are preferred. Demonstrated proficiency in using SAS to producederived analysis datasets and produce TFLs. Thorough understanding of clinical datastructures, relational database structures, and data exchange with alternatedata formats. Demonstrated skills in using additional softwaretools and applications (e.g. MS office, XML Demonstrated expertise in the handling andprocessing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM Demonstrated expertise in providingoutputs to meet downstream requirements, e.g., ADaM, Data Definition Table,e-submission. In-depth understanding of regulatory, industry,and technology standards and requirements. Good knowledge of statistical terminology,clinical tests, medical terminology, and protocol designs. Demonstrated ability to work in a teamenvironment with clinical team members. Good interpersonal, communication, writingand organizational skills.
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