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Clinical SAS Programmer
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cGxPServe 2 days ago Be among the first 25 applicants Join to apply for the
Clinical SAS Programmer
role at
cGxPServe Get AI-powered advice on this job and more exclusive features. Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications. Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Ensure timely delivery of all statistical deliverables for each study assigned. Collaborate with study statisticians and study team members to come up with timelines for statistical programming deliverables and other related action items. Follow departmental SOPs and processes for operational excellence. Lead statistical programming activities for regulatory submissions following CDISC standards. Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan. Take ownership for the completion of SDTM and ADAM specifications for assigned studies.
Responsibilities
Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications. Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Ensure timely delivery of all statistical deliverables for each study assigned. Collaborate with study statisticians and study team members to come up with timelines for statistical programming deliverables and other related action items. Follow departmental SOPs and processes for operational excellence. Lead statistical programming activities for regulatory submissions following CDISC standards. Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan. Take ownership for the completion of SDTM and ADAM specifications for assigned studies.
Requirements:
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation. Thorough knowledge of SDTM/ADaM specifications and programming. Strong SAS programming and graphic programming skills. Able to guide the successful completion of major programs and projects. Strong analytical and communication skills. Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies. Broad knowledge of medical/biological terminology in relevant therapeutic areas. Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings. Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses. Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submissions is a plus. Experience in management of CROs with respect to statistical programming. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for “SAS Developer” roles.
Denver, CO $62,200.00-$91,300.00 2 weeks ago Denver, CO $62,200.00-$91,300.00 2 weeks ago Broomfield, CO $77,618.50-$97,023.13 2 weeks ago Louisville, CO $94,874.00-$158,124.00 1 month ago Denver, CO $76,000.00-$104,000.00 6 days ago Sr Analyst, Analytics and Reporting (IKC)
Denver, CO $76,000.00-$104,000.00 3 weeks ago Sr Analyst, Analytics and Reporting (IKC)
Boulder, CO $137,000.00-$201,000.00 1 week ago Boulder, CO $150,000.00-$190,000.00 2 weeks ago Data Scientist/Solutions Engineer (TS/SCI)
Denver Metropolitan Area $150,000.00-$210,000.00 6 days ago Denver, CO $75,200.00-$110,400.00 3 weeks ago Broomfield, CO $50,000.00-$60,000.00 5 months ago Denver, CO $68,400.00-$100,400.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Clinical SAS Programmer
role at
cGxPServe 2 days ago Be among the first 25 applicants Join to apply for the
Clinical SAS Programmer
role at
cGxPServe Get AI-powered advice on this job and more exclusive features. Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications. Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Ensure timely delivery of all statistical deliverables for each study assigned. Collaborate with study statisticians and study team members to come up with timelines for statistical programming deliverables and other related action items. Follow departmental SOPs and processes for operational excellence. Lead statistical programming activities for regulatory submissions following CDISC standards. Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan. Take ownership for the completion of SDTM and ADAM specifications for assigned studies.
Responsibilities
Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications. Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Ensure timely delivery of all statistical deliverables for each study assigned. Collaborate with study statisticians and study team members to come up with timelines for statistical programming deliverables and other related action items. Follow departmental SOPs and processes for operational excellence. Lead statistical programming activities for regulatory submissions following CDISC standards. Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan. Take ownership for the completion of SDTM and ADAM specifications for assigned studies.
Requirements:
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation. Thorough knowledge of SDTM/ADaM specifications and programming. Strong SAS programming and graphic programming skills. Able to guide the successful completion of major programs and projects. Strong analytical and communication skills. Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies. Broad knowledge of medical/biological terminology in relevant therapeutic areas. Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings. Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses. Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submissions is a plus. Experience in management of CROs with respect to statistical programming. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for “SAS Developer” roles.
Denver, CO $62,200.00-$91,300.00 2 weeks ago Denver, CO $62,200.00-$91,300.00 2 weeks ago Broomfield, CO $77,618.50-$97,023.13 2 weeks ago Louisville, CO $94,874.00-$158,124.00 1 month ago Denver, CO $76,000.00-$104,000.00 6 days ago Sr Analyst, Analytics and Reporting (IKC)
Denver, CO $76,000.00-$104,000.00 3 weeks ago Sr Analyst, Analytics and Reporting (IKC)
Boulder, CO $137,000.00-$201,000.00 1 week ago Boulder, CO $150,000.00-$190,000.00 2 weeks ago Data Scientist/Solutions Engineer (TS/SCI)
Denver Metropolitan Area $150,000.00-$210,000.00 6 days ago Denver, CO $75,200.00-$110,400.00 3 weeks ago Broomfield, CO $50,000.00-$60,000.00 5 months ago Denver, CO $68,400.00-$100,400.00 2 weeks ago 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