Katalyst CRO
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SAS Programmer
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Katalyst CRO Overview
The statistical programming contractor independently manages completed projects that involve global tasks or cross-functional teams. The role may require providing inputs to design and analysis, reporting the results of clinical trials, and providing programming support for publications for marketed drugs. Primarily works at the study, product, or program level. Responsibilities
Provides comprehensive programming support, including development of programs, ADaM specifications, and analysis (datasets, TLGs) in compliance with regulatory requirements, departmental SOPs and work practices. Develops, debugs, and enhances SAS programs to support quality control of safety or efficacy derived datasets and TLGs. Manages and delivers assignments with quality and within timelines, independently and proactively. Provides programming support to CDISC-based e-submission. Implements programming standards and complies with regulatory requirements among project team members and across all projects; communicates project status and resource gaps to management. Standardizes deliverables (datasets and associated TLGs) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvement and proactively communicates issues impacting programming deliverables with Stat or DM team members. Influences communication toward common understanding and actionable results; tackles difficult problems and identifies solutions to support decision-making. Requirements
Bachelor's or master's degree in science, Statistics, Information Technology, or an equivalent combination of education and related work experience. Professional experience in a pharmaceutical or clinical research setting as a programmer (e.g., Bachelor's + 7 years or Master's + 6 years). Proficient knowledge of clinical trials and the drug development process, industry standards, and statistical concepts used in analysis and submissions of clinical trial data. Strong understanding of SDTM, ADaM standards and Implementation guides. Demonstrated proficiency in using SAS to produce analysis datasets, TLGs, eSUB components, and related software applications. Familiarity with Pinnacle 21, XML, and MS Office; ability to work independently and in a team environment. Expert level knowledge of CDISC-based e-submission (creation of ADaM datasets and associated TLGs in study/project). Solid knowledge of statistical models used for efficacy data analysis and advanced knowledge of government regulations (CDISC, ICH) pertaining to drug development across multiple therapeutic areas. Strong programming problem-solving skills and good oral and written communication abilities. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
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SAS Programmer
role at
Katalyst CRO Overview
The statistical programming contractor independently manages completed projects that involve global tasks or cross-functional teams. The role may require providing inputs to design and analysis, reporting the results of clinical trials, and providing programming support for publications for marketed drugs. Primarily works at the study, product, or program level. Responsibilities
Provides comprehensive programming support, including development of programs, ADaM specifications, and analysis (datasets, TLGs) in compliance with regulatory requirements, departmental SOPs and work practices. Develops, debugs, and enhances SAS programs to support quality control of safety or efficacy derived datasets and TLGs. Manages and delivers assignments with quality and within timelines, independently and proactively. Provides programming support to CDISC-based e-submission. Implements programming standards and complies with regulatory requirements among project team members and across all projects; communicates project status and resource gaps to management. Standardizes deliverables (datasets and associated TLGs) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvement and proactively communicates issues impacting programming deliverables with Stat or DM team members. Influences communication toward common understanding and actionable results; tackles difficult problems and identifies solutions to support decision-making. Requirements
Bachelor's or master's degree in science, Statistics, Information Technology, or an equivalent combination of education and related work experience. Professional experience in a pharmaceutical or clinical research setting as a programmer (e.g., Bachelor's + 7 years or Master's + 6 years). Proficient knowledge of clinical trials and the drug development process, industry standards, and statistical concepts used in analysis and submissions of clinical trial data. Strong understanding of SDTM, ADaM standards and Implementation guides. Demonstrated proficiency in using SAS to produce analysis datasets, TLGs, eSUB components, and related software applications. Familiarity with Pinnacle 21, XML, and MS Office; ability to work independently and in a team environment. Expert level knowledge of CDISC-based e-submission (creation of ADaM datasets and associated TLGs in study/project). Solid knowledge of statistical models used for efficacy data analysis and advanced knowledge of government regulations (CDISC, ICH) pertaining to drug development across multiple therapeutic areas. Strong programming problem-solving skills and good oral and written communication abilities. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
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