Sr. Statistical Programmer

Join to apply for the Sr. Statistical Programmer role at Katalyst CRO
.

New York, NY $65,885.00-$98,827.00

• Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
• Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
• Execute validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
• Develop and review CDISC SDTM and ADaM mapping specifications.
• Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
• Review datasets for any pending compliance issues and meticulously document identified issues.
• Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
• Generate utility macros and efficient code to streamline programming processes.
• Communicate effectively within project teams to ensure timely and budget‑compliant completion of assigned tasks.

• Master's degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 4 years of SAS programming experience. Alternatively, a bachelor's degree with at least 6 years of SAS programming experience.
• Minimum of 2 years of hands‑on CDISC implementation experience. Experience with R programming will be considered a significant plus.
• Proficiency in SAS programming.
• Previous involvement as a production or QC programmer at both product and study levels.
• Strong organizational, interpersonal, leadership, and communication skills.
• Ability to autonomously manage multiple tasks and projects.
• In‑depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
• Strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.

Associate

Contract

Information Technology

Pharmaceutical Manufacturing