cGxPServe Inc.
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
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Research, Analyst, and Information Technology Industries
Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for Statistical Programmer roles.
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Statistical Analyst or Enterprise Data Specialist
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Research, Analyst, and Information Technology Industries
Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for Statistical Programmer roles.
Chicago, IL $85,000.00-$110,000.00 15 hours ago Chicago, IL $141,000.00-$202,000.00 1 day ago Business Data Scientist, gTech Ads, Professional Services
Chicago, IL $141,000.00-$202,000.00 1 week ago Chicago, IL $170,000.00-$300,000.00 1 week ago Computational Modeling Associate Consultant
Quantitative Analyst - Expression of Interest
Chicago, IL $90,000.00-$120,000.00 4 weeks ago Chicago, IL $55,500.00-$63,116.00 1 day ago Greater Chicago Area $135,400.00-$186,175.00 1 week ago Chicago, IL $150,000.00-$200,000.00 2 days ago Chicago, IL $140,000.00-$240,000.00 2 weeks ago Chicago, IL $52,500.00-$83,500.00 2 hours ago Data Scientist/Python/ML/All Levels/Chicago
Statistical Analyst or Enterprise Data Specialist
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr