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Thứ Hai, 23 tháng 2, 2015

SAS Programmer (Remote) - Planet Pharma - Remote, OR

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Summary of Key Responsibilities: This position is responsible for statistical programming of Company clinical trials data. Duties and Responsibilities: • Create and review annotated CRF to SDTM datasets • Responsible for the translation of the SAP into programming specifications for analysis data model (ADaM) datasets • Create and review study specific documents such as validation plans, risk assessments, as appropriate • Review key study-related documents produced by other functions, such as case report forms, data management plan, and statistical analysis plan • Responsible for reviewing the SAP and the TFL specifications, and provide feedback to the statisticians • Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standards (custom study specific) datasets to be included in reports for submission to regulatory agencies, publications, and other communications as defined in specifications documents • Responsible for the development, review, validation, and execution of SAS programs to generate presentation-ready output (ie, Tables, Figures, and Listings), to be included in reports for submission to regulatory agencies, publications and other communications as defined in Statistical or Report Analysis Plans • Program the integration of databases from multiple studies or sources • Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities • Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision • Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget • Communicates effectively not only within the teams and functional lines but also with external resources • Assists with other duties as assigned • Carry out all activities according to Company SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP) • Adapts to changing circumstances, policies, work assignments, and/or team members. Able to multi-task and prioritize between tasks Summary of Key Responsibilities: This position is responsible for statistical programming of Company clinical trials data. Duties and Responsibilities: • Create and review annotated CRF to SDTM datasets • Responsible for the translation of the SAP into programming specifications for analysis data model (ADaM) datasets • Create and review study specific documents such as validation plans, risk assessments, as appropriate • Review key study-related documents produced by other functions, such as case report forms, data management plan, and statistical analysis plan • Responsible for reviewing the SAP and the TFL specifications, and provide feedback to the statisticians • Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standards (custom study specific) datasets to be included in reports for submission to regulatory agencies, publications, and other communications as defined in specifications documents • Responsible for the development, review, validation, and execution of SAS programs to generate presentation-ready output (ie, Tables, Figures, and Listings), to be included in reports for submission to regulatory agencies, publications and other communications as defined in Statistical or Report Analysis Plans • Program the integration of databases from multiple studies or sources • Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities • Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision • Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget • Communicates effectively not only within the teams and functional lines but also with external resources • Assists with other duties as assigned • Carry out all activities according to Company SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP) • Adapts to changing circumstances, policies, work assignments, and/or team members. Able to multi-task and prioritize between tasks

Education and Requirements: Bachelor’s Degree Master’s in Statistics preferred not required 1-3 years of Clinical Programming for a Pharma / Biotech or CRO – Academic exp will not be accepted 1-3 years with CDISC – AdaM and SDTM




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