Katalyst CRO
Overview
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Lead Statistical Programmer
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Katalyst CRO 1 month ago Be among the first 25 applicants Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables. Lead or contribute to the development, validation, and documentation of SDTM, ADaM, and TFLs in support of clinical study reports, regulatory submissions, publications, and ad-hoc requests. Collaborate closely with Biostatisticians, Data Management, and Clinical teams to review SAPs, TLF shells, and data specifications to ensure alignment and clarity. Provide expert input and review of programming assumptions, table shells, and analysis specifications. Support the preparation of define.xml, e-submission-ready packages, and work with tools such as Pinnacle 21 for compliance checking. Ensure programming deliverables meet regulatory standards and are consistent with CDISC and company-defined specifications. Oversee CRO deliverables as needed, with a focus on technical quality and consistency rather than operational management. Contribute to the development and optimization of programming standards, templates, and macros to improve team efficiency and quality. Collaborate with leadership on the design and enhancement of the Statistical Computing Environment (SCE), including folder structures, version control, and access management. Evaluate and implement innovative tools and programming technologies to streamline processes. Responsibilities
Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables. Lead or contribute to the development, validation, and documentation of SDTM, ADaM, and TFLs in support of clinical study reports, regulatory submissions, publications, and ad-hoc requests. Collaborate closely with Biostatisticians, Data Management, and Clinical teams to review SAPs, TLF shells, and data specifications to ensure alignment and clarity. Provide expert input and review of programming assumptions, table shells, and analysis specifications. Support the preparation of define.xml, e-submission-ready packages, and work with tools such as Pinnacle 21 for compliance checking. Ensure programming deliverables meet regulatory standards and are consistent with CDISC and company-defined specifications. Oversee CRO deliverables as needed, with a focus on technical quality and consistency rather than operational management. Contribute to the development and optimization of programming standards, templates, and macros to improve team efficiency and quality. Collaborate with leadership on the design and enhancement of the Statistical Computing Environment (SCE), including folder structures, version control, and access management. Evaluate and implement innovative tools and programming technologies to streamline processes. Requirements
Master's degree in Statistics, Biostatistics, Computer Science, or a related field. Minimum of 8 years of statistical programming experience in the pharmaceutical, biotech, or CRO environment. Expertise in SAS, R, CDISC standards, and regulatory submission requirements. Deep understanding and hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements. Strong knowledge of statistical concepts, clinical trial design, data standards, and regulatory expectations (e.g., FDA, EMA, PMDA). Proven ability to independently produce high-quality analysis datasets, tables, listings, and figures for regulatory and publication purposes. Experience in working with tools like Pinnacle 21, define.xml, and other clinical data standards tools. Demonstrated ability to collaborate effectively in cross-functional settings and manage competing priorities in a fast-paced or startup environment. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
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Join to apply for the
Lead Statistical Programmer
role at
Katalyst CRO 1 month ago Be among the first 25 applicants Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables. Lead or contribute to the development, validation, and documentation of SDTM, ADaM, and TFLs in support of clinical study reports, regulatory submissions, publications, and ad-hoc requests. Collaborate closely with Biostatisticians, Data Management, and Clinical teams to review SAPs, TLF shells, and data specifications to ensure alignment and clarity. Provide expert input and review of programming assumptions, table shells, and analysis specifications. Support the preparation of define.xml, e-submission-ready packages, and work with tools such as Pinnacle 21 for compliance checking. Ensure programming deliverables meet regulatory standards and are consistent with CDISC and company-defined specifications. Oversee CRO deliverables as needed, with a focus on technical quality and consistency rather than operational management. Contribute to the development and optimization of programming standards, templates, and macros to improve team efficiency and quality. Collaborate with leadership on the design and enhancement of the Statistical Computing Environment (SCE), including folder structures, version control, and access management. Evaluate and implement innovative tools and programming technologies to streamline processes. Responsibilities
Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables. Lead or contribute to the development, validation, and documentation of SDTM, ADaM, and TFLs in support of clinical study reports, regulatory submissions, publications, and ad-hoc requests. Collaborate closely with Biostatisticians, Data Management, and Clinical teams to review SAPs, TLF shells, and data specifications to ensure alignment and clarity. Provide expert input and review of programming assumptions, table shells, and analysis specifications. Support the preparation of define.xml, e-submission-ready packages, and work with tools such as Pinnacle 21 for compliance checking. Ensure programming deliverables meet regulatory standards and are consistent with CDISC and company-defined specifications. Oversee CRO deliverables as needed, with a focus on technical quality and consistency rather than operational management. Contribute to the development and optimization of programming standards, templates, and macros to improve team efficiency and quality. Collaborate with leadership on the design and enhancement of the Statistical Computing Environment (SCE), including folder structures, version control, and access management. Evaluate and implement innovative tools and programming technologies to streamline processes. Requirements
Master's degree in Statistics, Biostatistics, Computer Science, or a related field. Minimum of 8 years of statistical programming experience in the pharmaceutical, biotech, or CRO environment. Expertise in SAS, R, CDISC standards, and regulatory submission requirements. Deep understanding and hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements. Strong knowledge of statistical concepts, clinical trial design, data standards, and regulatory expectations (e.g., FDA, EMA, PMDA). Proven ability to independently produce high-quality analysis datasets, tables, listings, and figures for regulatory and publication purposes. Experience in working with tools like Pinnacle 21, define.xml, and other clinical data standards tools. Demonstrated ability to collaborate effectively in cross-functional settings and manage competing priorities in a fast-paced or startup environment. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr