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# Sr. Statistical Programmer

- **Company:** Katalyst Talent Agency
- **Location:** Cincinnati, OH, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Coherent Remote File System (CRFS), R (Programming Language), Python (Programming Language), SAS (Software), SAS/STAT, SQL Databases, Utility Software, Macros, Information Technology, Spotfire
- **Published:** October 27, 2026
- **Apply:** https://www.careerjet.com/job/usf275df189310d9975c74482b826ef9d0/eaa

## About the Role

* Bachelor's degree in Statistics, Mathematics, Computer Science or a related field required
 * Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer
 * Prior experience overseeing statistical programming contractors required
 * Compound oversight experience highly preferred
 * Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
 * Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred
 * Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines
 * eCTD NDA submission experience is a must.

## Description

* Ensure departmental or functional training plans in place and appropriate
 * Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget
 * Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications
 * Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications
 * Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports)
 * Maintain complete and auditable documentation of all programming activities
 * Manage datasets and output across SAS programs, studies, and indications to ensure consistency
 * Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests
 * Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures
 * Develop and/or maintain departmental procedures and standards
 * Review CRFs, edit check specifications, and table, figure, and listing mock-ups
 * Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer's guide documents
 * Assist in validation of SAS per 21 CFR Part 11
 * Train and mentor new members and programmers; supervise contract programmers, as needed