Sr. SAS Programmer Job Summary This position will require programming as well as some statistical analysis functions as required in our CDx program. It is certainly preferable for the candidate to have knowledge of biomarkers and analysis methods to enable us to evaluate all of our biomarker data and ensure the quality and accuracy of our data. The candidate will need to perform a quality check on all of our data and this is generally possible to do this programmatically. The job will involve communication with Eisai Statisticians and programmers and external programmers and statisticians. The candidate will ideally have the capability to learn statistical analysis methods based on external statisticians examples and publications and will have completed complex biomarker analysis as we require for CDx development including the identification of biomarker cut points and the evaluation of the predictive and or prognostic value of single or multiplexed biomarkers. The CDx department develops data that is often contributing to FDA and Regulatory submissions so it is imperative our data goes through a rigorous review process and this role is required to enable this to be accomplished. Essential Functions Review and provides guidance on the development of Statistical Analysis Plans for our Biomarker studies including Analytical and Clinical Validation Studies. SAS programming to enable validation of Analysis Data Sets from external and internal validation studies and clinical trial data sets. Development of data transfer plans and development of data specification tables as well as communication with both internal and external statisticians and programmers to ensure the data is generated as needed by our internal development programs. Transfer of excel data files into SAS data format to enable validation and Quality reviews of data. Assist in the QC and review of data analyses for all of the CDx and diagnostic biomarker projects. Complete in-house validation of data received from external CROs and vendors as required by our internal processes and procedures. This validation includes the receipt of the SAS programming and a check on the programming and results involving a repeat of the data generated based on Clinical and Validation Study Data sets (Tables, Listings and Figures. Complete complex statistical analyses to evaluate the prognostic, predictive value of biomarkers and to identify optimal cut points for the best assay performance. Analysis includes Kaplan Meier plots, scatterplots, univariate and multivariate cox proportional hazards modeling for single biomarkers and multiplexed panels of biomarkers. This position will enable the quality review of clinical research data, clinical data to ensure accuracy and quality of the final data used for the development of reports that support regulatory submission of our companion diagnostic data. Position will include communication with members of the Biostatistics group in other company locations as part of the coordination of effort for various clinical programs. Position will have the responsibility for making decisions regarding the validation and quality review of data. KnowledgeSkillsAbilities Required Certified SAS Base or Advanced Programmer with a BS or MS in Computer Science andor Statistics. A minimum of 7 or more years of experience working with clinical research or clinical development programs in the pharmaceutical or biopharmaceutical industry. Proficient with various regulatory requirements for data analysis programming including ICH 21 for Clinical and SAS programming, CDISC Analysis Data Model, SDTM and Adam analysis data models. Experience in programming, analyzing and reporting in various SDTM domains using SAS on Windows environments. Experience and proficient with excel and sorting and merging of data with ability to create tables, graphs, plots and develop PowerPoint presentations. Knowledgeable about Drug Development Process with experience in analyzing, validating and reporting Pre-clinical and Phase I-IV clinical Trial data. Proficiency in development of Study Protocols, SAP (Statistical Analysis Plan) and CRFs with experience in Extracting data sets from various sources like Excel. Expertise in producing RTF, PDF, HTML files using SAS ODS Facility. Preferable to have experience in programming, validation and evaluation of diagnostic, biomarker or companion diagnostic development data. Associated topics: algorithm, back end, devops, java, programming, python, sde, software developer, software engineer, sw
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