Katalyst CRO
Overview
Sr. Statistical Programmer role at Katalyst CRO. This position uses statistical programming software to develop datasets and tables, figures, and listings that comply with regulatory standards and support the analysis, reporting, interpretation, and publication of clinical trial data. Responsibilities
Ensure that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with regulatory standards. Assess study datasets and resolve deviations from CDISC using Pinnacle21 or other quality tools. Maintain a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology. Provide technical consultation and collaborate with internal and external stakeholders to facilitate understanding of statistical programming services. Support collaboration with Data Management to facilitate SDTM development. Develop programming efficiencies (eg, local macros) to ensure efficient programming work. Support the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics. Develop specification documents for datasets and supporting documents (eg, define.xml, annotated CRFs, reviewer7s guides). Develop programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies. Lead and manage statistical programming priorities and task assignments for clinical studies and submissions. Track and escalate concerns related to changes in scope of services. Mentor junior statistical programmers. Requirements
Bachelor\'s or master\'s degree or international equivalent in Biostatistics, Statistics, or a 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. 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. Excellent verbal and written communication skills. Good planning and organizational skills with the ability to adapt to changing priorities. Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment. A strong interest in developing expertise in ophthalmology. Seniority level
Not Applicable Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
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Sr. Statistical Programmer role at Katalyst CRO. This position uses statistical programming software to develop datasets and tables, figures, and listings that comply with regulatory standards and support the analysis, reporting, interpretation, and publication of clinical trial data. Responsibilities
Ensure that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with regulatory standards. Assess study datasets and resolve deviations from CDISC using Pinnacle21 or other quality tools. Maintain a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology. Provide technical consultation and collaborate with internal and external stakeholders to facilitate understanding of statistical programming services. Support collaboration with Data Management to facilitate SDTM development. Develop programming efficiencies (eg, local macros) to ensure efficient programming work. Support the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics. Develop specification documents for datasets and supporting documents (eg, define.xml, annotated CRFs, reviewer7s guides). Develop programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies. Lead and manage statistical programming priorities and task assignments for clinical studies and submissions. Track and escalate concerns related to changes in scope of services. Mentor junior statistical programmers. Requirements
Bachelor\'s or master\'s degree or international equivalent in Biostatistics, Statistics, or a 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. 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. Excellent verbal and written communication skills. Good planning and organizational skills with the ability to adapt to changing priorities. Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment. A strong interest in developing expertise in ophthalmology. Seniority level
Not Applicable Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr