Katalyst CRO
Statistical Programmer
Katalyst CRO - Chicago, Illinois, United States, 60290
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Overview
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Statistical Programmer
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Statistical Programmer
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Katalyst CRO Get AI-powered advice on this job and more exclusive features. Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis. Develop and maintain SDTM domains in accordance with CDISC guidance. Create and optimize Adam datasets, Tables, Figures, Listings (TFLs) and Analysis content. Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications. Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities. Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis. Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
Responsibilities
Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis. Develop and maintain SDTM domains in accordance with CDISC guidance. Create and optimize Adam datasets, Tables, Figures, Listings (TFLs) and Analysis content. Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications. Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities. Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis. Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
Requirements:
Minimum of a bachelor's degree required; MS degree is preferred (statistics, biostatistics, or closely related field). 5 years' experience with SAS and clinical programming within the biotech / pharmaceutical industry. Proficiency in SAS programming, including experience with SAS macro language, data step programming, and PROC SQL. Strong knowledge of CDISC and CDASH standards, including SDTM and Adam datasets, and experience with regulatory submission requirements. Experience with clinical trial data and understanding of the drug development process. Knowledge of regulatory guidelines, including FDA, EMA, and ICH, related to statistical programming and clinical trials. Experience with statistical programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
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Statistical Programmer
role at
Katalyst CRO 1 month ago Be among the first 25 applicants Join to apply for the
Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis. Develop and maintain SDTM domains in accordance with CDISC guidance. Create and optimize Adam datasets, Tables, Figures, Listings (TFLs) and Analysis content. Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications. Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities. Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis. Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
Responsibilities
Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis. Develop and maintain SDTM domains in accordance with CDISC guidance. Create and optimize Adam datasets, Tables, Figures, Listings (TFLs) and Analysis content. Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications. Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities. Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis. Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
Requirements:
Minimum of a bachelor's degree required; MS degree is preferred (statistics, biostatistics, or closely related field). 5 years' experience with SAS and clinical programming within the biotech / pharmaceutical industry. Proficiency in SAS programming, including experience with SAS macro language, data step programming, and PROC SQL. Strong knowledge of CDISC and CDASH standards, including SDTM and Adam datasets, and experience with regulatory submission requirements. Experience with clinical trial data and understanding of the drug development process. Knowledge of regulatory guidelines, including FDA, EMA, and ICH, related to statistical programming and clinical trials. Experience with statistical programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Statistical Programmer roles.
Chicago, IL $85,000.00-$110,000.00 1 month ago Fully Funded Tech Fellowship for Recent Grads in Chicago
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