Katalyst CRO
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Statistical Programmer
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Katalyst CRO 6 days ago Be among the first 25 applicants Join to apply for the
Statistical Programmer
role at
Katalyst CRO 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. Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines. Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.
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. Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines. Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.
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. Proficiency in industry standards, medical terminology, and clinical trial methodologies. Excellent problem-solving skills and attention to detail, with the ability to work independently and manage multiple projects simultaneously. Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. 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 6 days ago Be among the first 25 applicants Join to apply for the
Statistical Programmer
role at
Katalyst CRO 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. Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines. Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.
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. Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines. Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.
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. Proficiency in industry standards, medical terminology, and clinical trial methodologies. Excellent problem-solving skills and attention to detail, with the ability to work independently and manage multiple projects simultaneously. Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. 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.
Denver, CO $65,000.00-$190,000.00 2 weeks ago Business and Marketing Data Scientist, YouTube, Creative Research
Boulder, CO $141,000.00-$202,000.00 1 week ago Denver, CO $50,000.00-$70,000.00 2 months ago Denver, CO $180,000.00-$200,000.00 2 weeks ago DOLA Data Analyst (Statistical Analyst II)-Term Limited.
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Denver, CO $65,000.00-$85,000.00 5 days ago Denver, CO $150,000.00-$175,000.00 1 month ago Syndromic Surveillance Data Analyst - Statistical Analyst II
Denver, CO $49,977.51-$109,950.52 1 month ago Louisville, CO $94,874.00-$158,124.00 2 months ago Research Associate-Quantitative Data Manager and Analyst
Boulder, CO $85,000.00-$105,000.00 5 days ago Louisville, CO $94,874.00-$158,124.00 1 month ago Denver, CO $61,244.98-$134,738.95 2 months ago Early Childhood Workforce Research & Reporting Analyst.
Broomfield, CO $131,000.00-$200,790.00 2 weeks ago Denver, CO $85,000.00-$115,000.00 6 days ago Boulder, CO $150,000.00-$190,000.00 2 weeks ago Denver, CO $62,200.00-$91,300.00 7 hours ago Principle Data Scientist(GenAI)- Only Locals and W2
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