Katalyst CRO
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Sr. Statistical Programmer
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Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Sr. Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies, Sponsors, and SOPs. Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools. Maintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology. Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM development. Develops programming efficiencies (eg, local macros) to ensure efficient programming work. Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics. Develops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer's guides) as detailed in SOPs. Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies. Leads and manages statistical programming priorities and task assignments for clinical studies and submissions. Tracks and escalates concerns related to changes in scope of services. Mentors' junior statistical programmers.
Responsibilities
Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies, Sponsors, and SOPs. Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools. Maintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology. Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM development. Develops programming efficiencies (eg, local macros) to ensure efficient programming work. Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics. Develops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer's guides) as detailed in SOPs. Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies. Leads and manages statistical programming priorities and task assignments for clinical studies and submissions. Tracks and escalates concerns related to changes in scope of services. Mentors' junior statistical programmers.
Requirements
Bachelor's or master's degree or international equivalent in Biostatistics, Statistics, or programming-related field. 5 or more years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead, preferred. A high level of SAS programming skills including SQL and macro development. Good knowledge and application of CDISC standards for SDTM and ADaM. Experience with Pinnacle21 and writing reviewer's guides is a plus. Basic understanding of standard statistical methodologies is expected. Experience with ophthalmology is preferred. Good understanding of statistical programming topics in medical product development. Excellent technical and programming logic skills. A successful history of cross-functional collaboration. Sound knowledge of all relevant regulations and guidelines. A strong interest in developing expertise in ophthalmology. Excellent verbal and written communication skills. Good planning and organizational skills with the ability to adapt and adjust to changing priorities. Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Research, Analyst, and Information Technology Industries
Biotechnology Research and IT Services and IT Consulting Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Senior Statistical Programmer roles.
Salt Lake City, UT $60,700.00-$85,000.00 3 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Sr. Statistical Programmer
role at
Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Sr. Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies, Sponsors, and SOPs. Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools. Maintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology. Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM development. Develops programming efficiencies (eg, local macros) to ensure efficient programming work. Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics. Develops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer's guides) as detailed in SOPs. Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies. Leads and manages statistical programming priorities and task assignments for clinical studies and submissions. Tracks and escalates concerns related to changes in scope of services. Mentors' junior statistical programmers.
Responsibilities
Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies, Sponsors, and SOPs. Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools. Maintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology. Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM development. Develops programming efficiencies (eg, local macros) to ensure efficient programming work. Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics. Develops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer's guides) as detailed in SOPs. Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies. Leads and manages statistical programming priorities and task assignments for clinical studies and submissions. Tracks and escalates concerns related to changes in scope of services. Mentors' junior statistical programmers.
Requirements
Bachelor's or master's degree or international equivalent in Biostatistics, Statistics, or programming-related field. 5 or more years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead, preferred. A high level of SAS programming skills including SQL and macro development. Good knowledge and application of CDISC standards for SDTM and ADaM. Experience with Pinnacle21 and writing reviewer's guides is a plus. Basic understanding of standard statistical methodologies is expected. Experience with ophthalmology is preferred. Good understanding of statistical programming topics in medical product development. Excellent technical and programming logic skills. A successful history of cross-functional collaboration. Sound knowledge of all relevant regulations and guidelines. A strong interest in developing expertise in ophthalmology. Excellent verbal and written communication skills. Good planning and organizational skills with the ability to adapt and adjust to changing priorities. Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Research, Analyst, and Information Technology Industries
Biotechnology Research and IT Services and IT Consulting Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Senior Statistical Programmer roles.
Salt Lake City, UT $60,700.00-$85,000.00 3 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr