Katalyst CRO
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Senior Statistical Programmer
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Katalyst CRO
Support the Biostatistics team by carrying out programming activities of statistical programmers and work closely with clinicians, programmers, study team and publication managers to generate QC output; and ensure timely and accurate programming and validation activities for clinical studies and publications. Review abstract/manuscripts (publication) to ensure accuracy, quality and soundness of statistical methodologies, and oversee external vendors as required. Main duties/responsibilities include providing statistical programming and validation support for clinical study reports and publications, overseeing programming activities by external vendors (e.g., CROs), and coordinating programming activities among study programmers to achieve timely progress in areas such as SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other requests. Collaborate with the clinical study team on study design and review of clinical study protocols. Work closely with clinicians, statisticians, and publication managers to generate and QC outputs for publications, and review publications to ensure accuracy and quality of statistical methodologies. Coordinate with project statisticians and data managers on study design, data transfer specifications, and participate in user acceptance testing (UAT). Generate and review data tables and listings, and coordinate data review meetings to ensure data quality. Provide input for the development of databases and CRFs, create edit check programs, and give feedback to Data Management. Contribute to the development of statistical analysis plans and related documents. Work independently to accomplish tasks, introduce new ideas to improve the programming process, and maintain standards for programming activities. Oversee CRO programming activities, perform quality assurance checks on SAS tables, listings, and figures, and ensure the quality of CRO deliverables. May also work on submission teams as a statistician and/or programmer. #J-18808-Ljbffr
Senior Statistical Programmer
role at
Katalyst CRO
Support the Biostatistics team by carrying out programming activities of statistical programmers and work closely with clinicians, programmers, study team and publication managers to generate QC output; and ensure timely and accurate programming and validation activities for clinical studies and publications. Review abstract/manuscripts (publication) to ensure accuracy, quality and soundness of statistical methodologies, and oversee external vendors as required. Main duties/responsibilities include providing statistical programming and validation support for clinical study reports and publications, overseeing programming activities by external vendors (e.g., CROs), and coordinating programming activities among study programmers to achieve timely progress in areas such as SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other requests. Collaborate with the clinical study team on study design and review of clinical study protocols. Work closely with clinicians, statisticians, and publication managers to generate and QC outputs for publications, and review publications to ensure accuracy and quality of statistical methodologies. Coordinate with project statisticians and data managers on study design, data transfer specifications, and participate in user acceptance testing (UAT). Generate and review data tables and listings, and coordinate data review meetings to ensure data quality. Provide input for the development of databases and CRFs, create edit check programs, and give feedback to Data Management. Contribute to the development of statistical analysis plans and related documents. Work independently to accomplish tasks, introduce new ideas to improve the programming process, and maintain standards for programming activities. Oversee CRO programming activities, perform quality assurance checks on SAS tables, listings, and figures, and ensure the quality of CRO deliverables. May also work on submission teams as a statistician and/or programmer. #J-18808-Ljbffr