Katalyst CRO
Principal Statistical Programmer
Katalyst CRO, Redwood City, California, United States, 94061
Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO Responsible for leading study team through end-to-end regulatory submission activities. Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs. Perform validation and QC of the programs, datasets, and statistical reports per study requirements. Authors ADaM dataset specifications including the identification of potential data issues or areas of critical data examination. Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components. Other related programming activities. Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed. Participate in hiring and onboarding of operational FSP programmers.
Responsibilities
Responsible for leading study team through end-to-end regulatory submission activities. Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs. Perform validation and QC of the programs, datasets, and statistical reports per study requirements. Authors ADaM dataset specifications including the identification of potential data issues or areas of critical data examination. Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components. Other related programming activities. Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed. Participate in hiring and onboarding of operational FSP programmers.
Requirements
5+ years of Statistical SAS Programming experience within the life science industry, preferably on the Sponsor side. Must have recent experience as the lead programmer for a regulatory submission, leading statistical programming efforts and activities. Must have management experience including oversight, work assignment and productivity management of other programmers. Needs to understand complex studies and have end-to-end regulatory submissions experience. Safety and efficacy experience (ISS/Client) is required. Must have experience performing data manipulation, analysis and reporting of clinical trial data. Strong knowledge of CDISC (must be skilled with ADaM and SDTM). Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
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Principal Statistical Programmer
role at
Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO Responsible for leading study team through end-to-end regulatory submission activities. Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs. Perform validation and QC of the programs, datasets, and statistical reports per study requirements. Authors ADaM dataset specifications including the identification of potential data issues or areas of critical data examination. Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components. Other related programming activities. Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed. Participate in hiring and onboarding of operational FSP programmers.
Responsibilities
Responsible for leading study team through end-to-end regulatory submission activities. Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs. Perform validation and QC of the programs, datasets, and statistical reports per study requirements. Authors ADaM dataset specifications including the identification of potential data issues or areas of critical data examination. Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components. Other related programming activities. Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed. Participate in hiring and onboarding of operational FSP programmers.
Requirements
5+ years of Statistical SAS Programming experience within the life science industry, preferably on the Sponsor side. Must have recent experience as the lead programmer for a regulatory submission, leading statistical programming efforts and activities. Must have management experience including oversight, work assignment and productivity management of other programmers. Needs to understand complex studies and have end-to-end regulatory submissions experience. Safety and efficacy experience (ISS/Client) is required. Must have experience performing data manipulation, analysis and reporting of clinical trial data. Strong knowledge of CDISC (must be skilled with ADaM and SDTM). Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
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