Sr. Statistical Programmer

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

Seniority level

Mid?Senior level

Employment type

Contract

Job function

Information Technology

Industries

Pharmaceutical Manufacturing

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