Katalyst CRO
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Clinical SAS programmer
role at
Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the
Clinical SAS programmer
role at
Katalyst CRO Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Attending multi-disciplinary team meetings, representing the programming function. Develop software systems to generate displays of clinal al study data as tables, listings, and graphs for electronic submission to regulatory agencies. Assist statisticians by suggesting algorithms to address Client analysis requests. Develop software validation procedures and test plans, as necessary. Create and document archives of software, outputs, and analysis files. Create and maintain department SOPs related to clinical programming. Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately. Provide time and resource estimates for project planning. Oversee work of internal contract programmers and external vendors.
Responsibilities
Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Attending multi-disciplinary team meetings, representing the programming function. Develop software systems to generate displays of clinal al study data as tables, listings, and graphs for electronic submission to regulatory agencies. Assist statisticians by suggesting algorithms to address Client analysis requests. Develop software validation procedures and test plans, as necessary. Create and document archives of software, outputs, and analysis files. Create and maintain department SOPs related to clinical programming. Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately. Provide time and resource estimates for project planning. Oversee work of internal contract programmers and external vendors.
Requirements
Bachelor's degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; master's degree preferred. Minimum 6 years of experience in developing software for clinical trials using the SAS system Skilled in programming with SAS, Knowledge of additional programming languages a plus. Good knowledge of statistics and drug development process Experience as a lead programmer for NDAs/BLAs Experience overseeing the work of internal contractors and external vendors (CROs) Experience in pharmacokinetics/pharmacodynamics modeling a plus. Familiarity with CDISC standards, including SDTM and ADaM models. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
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Clinical SAS programmer
role at
Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the
Clinical SAS programmer
role at
Katalyst CRO Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Attending multi-disciplinary team meetings, representing the programming function. Develop software systems to generate displays of clinal al study data as tables, listings, and graphs for electronic submission to regulatory agencies. Assist statisticians by suggesting algorithms to address Client analysis requests. Develop software validation procedures and test plans, as necessary. Create and document archives of software, outputs, and analysis files. Create and maintain department SOPs related to clinical programming. Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately. Provide time and resource estimates for project planning. Oversee work of internal contract programmers and external vendors.
Responsibilities
Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Attending multi-disciplinary team meetings, representing the programming function. Develop software systems to generate displays of clinal al study data as tables, listings, and graphs for electronic submission to regulatory agencies. Assist statisticians by suggesting algorithms to address Client analysis requests. Develop software validation procedures and test plans, as necessary. Create and document archives of software, outputs, and analysis files. Create and maintain department SOPs related to clinical programming. Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately. Provide time and resource estimates for project planning. Oversee work of internal contract programmers and external vendors.
Requirements
Bachelor's degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; master's degree preferred. Minimum 6 years of experience in developing software for clinical trials using the SAS system Skilled in programming with SAS, Knowledge of additional programming languages a plus. Good knowledge of statistics and drug development process Experience as a lead programmer for NDAs/BLAs Experience overseeing the work of internal contractors and external vendors (CROs) Experience in pharmacokinetics/pharmacodynamics modeling a plus. Familiarity with CDISC standards, including SDTM and ADaM models. Seniority level
Seniority level Mid-Senior level 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 Get notified about new SAS Developer jobs in
Chicago, IL . Chicago, IL $65,000.00-$70,000.00 4 days ago Chicago, IL $80,000.00-$85,000.00 1 week ago Bensenville, IL $60,000.00-$80,000.00 2 days ago Chicago, IL $60,000.00-$80,000.00 2 weeks ago Technical Data Analyst/Engineer (MicroStrategy)
Chicago, IL $51,700.00-$101,500.00 20 hours ago Chicago, IL $88,500.00-$98,300.00 1 week ago Chicago, IL $110,000.00-$130,000.00 1 day ago Chicago, IL $79,300.00-$127,000.00 2 days ago Bensenville, IL $60,000.00-$80,000.00 1 hour ago Chicago, IL $70,000.00-$85,000.00 1 month ago Data Modeler - BI Analytics - Onsite (Full Time)
Chicago, IL $100,000.00-$120,000.00 1 month ago Entry Level Data Analyst, application via RippleMatch
Chicago, IL $96,142.00-$132,195.00 3 weeks ago Junior Analyst – Pharmacy Insights – SQL
Junior Data Reporting Analyst – Strategic Analysis
Fully Funded Tech Fellowship for Recent Grads in Chicago
Chicago, IL $95,600.00-$162,400.00 6 days ago Data Analyst Intern, application via RippleMatch
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr