Katalyst CRO
We are seeking a highly motivated and qualified Senior Statistical Programmer to join the Clinical Department at Katalyst CRO. The role involves leading statistical programming activities, designing, developing, validating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs that support regulatory filings and internal reporting.
Responsibilities
Independently develop, validate, document, and troubleshoot SAS programs for the preparation of periodic internal reports, regulatory submissions, and ad hoc analyses. Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. Design, develop, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner. Support submission activities including preparation of data packages, eCTD deliverables, and responses to regulatory agencies. Communicate with team members about statistical programming related to trial timelines, data quality, and results interpretation. Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality. Create SAS macros or other tools to enhance the efficient delivery of statistical services, providing associated documentation and staff training as needed. Program quality checks for clinical study raw data and report findings. Review or author SDTM and ADaM specifications and datasets. Manage CROs, including reviewing or validating statistical deliverables of vendors. Provide input in the design and development of case report forms. Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience. Establish and maintain excellent working relationships with critical collaborative partners throughout the company. Requirements
Bachelor’s degree in Biostatistics, Mathematics, Statistics, Computer Science, or related field. Minimum 6 years’ experience in bio‑pharma statistical programming. Advanced SAS programming skills in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures. Strong expertise in CDISC including SDTM, ADaM, and CDASH. Extensive experience in SAS macro functions and dynamic code generation. Experience in regulatory submissions (e.g., NDAs and DSURs). High attention to detail, with a focus on quality and traceability in all deliverables. Strong interpersonal and teamwork skills with a collaborative mindset and the ability to manage multiple priorities in a fast‑paced and dynamic environment with shifting timelines and evolving needs. Take initiatives to solve problems proactively and think critically. Willing to adapt to changing business needs, able to pivot between tasks. Able to make complex programming and data‑related decisions independently. Comprehensive knowledge and deep understanding of statistical programming environments, processes, procedures, and roles for clinical development from Phase 1 through regulatory submission. Up‑to‑date with CDISC standards, industry trends, best practices, and statistical programming methodology. Seniority level
Mid‑Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
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Independently develop, validate, document, and troubleshoot SAS programs for the preparation of periodic internal reports, regulatory submissions, and ad hoc analyses. Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. Design, develop, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner. Support submission activities including preparation of data packages, eCTD deliverables, and responses to regulatory agencies. Communicate with team members about statistical programming related to trial timelines, data quality, and results interpretation. Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality. Create SAS macros or other tools to enhance the efficient delivery of statistical services, providing associated documentation and staff training as needed. Program quality checks for clinical study raw data and report findings. Review or author SDTM and ADaM specifications and datasets. Manage CROs, including reviewing or validating statistical deliverables of vendors. Provide input in the design and development of case report forms. Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience. Establish and maintain excellent working relationships with critical collaborative partners throughout the company. Requirements
Bachelor’s degree in Biostatistics, Mathematics, Statistics, Computer Science, or related field. Minimum 6 years’ experience in bio‑pharma statistical programming. Advanced SAS programming skills in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures. Strong expertise in CDISC including SDTM, ADaM, and CDASH. Extensive experience in SAS macro functions and dynamic code generation. Experience in regulatory submissions (e.g., NDAs and DSURs). High attention to detail, with a focus on quality and traceability in all deliverables. Strong interpersonal and teamwork skills with a collaborative mindset and the ability to manage multiple priorities in a fast‑paced and dynamic environment with shifting timelines and evolving needs. Take initiatives to solve problems proactively and think critically. Willing to adapt to changing business needs, able to pivot between tasks. Able to make complex programming and data‑related decisions independently. Comprehensive knowledge and deep understanding of statistical programming environments, processes, procedures, and roles for clinical development from Phase 1 through regulatory submission. Up‑to‑date with CDISC standards, industry trends, best practices, and statistical programming methodology. Seniority level
Mid‑Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr