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Katalyst CRO

Sr. SAS Programmer

Katalyst CRO, Chicago, Illinois, United States

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Sr. SAS Programmer Join to apply for the Sr. SAS Programmer role at

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Responsibilities:

Support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), ensuring timely and accurate programming and validation activities for clinical studies and publications.

Contribute to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.

Provide statistical programming and validation support for clinical study reports, oversee programming activities by external vendors (e.g., CROs) when necessary and coordinate programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., Publications).

Access and convert data to SAS from database management systems and PC file formats (e.g., MS Excel, text files).

Work with external vendors to develop or monitor the content and structure of SAS data sets.

Work closely with clinicians, statisticians, and publication managers to generate and QC outputs for publications; review publication abstracts/manuscripts to ensure accuracy, quality, and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activity metrics for management review.

Provide input to the database and CRF development, create edit check programs, and provide feedback to the Data Management team.

Provide input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.

Maintain standards for programming activities.

Work independently to accomplish tasks and goals defined by supervisor.

Bring in new ideas to improve the programming process.

Requirements:

Minimum of a bachelor’s degree in a related science discipline.

Minimum 7+ years’ experience in SAS programming for Phase I–IV clinical trials in a pharmaceutical/CRO environment.

Experience using SAS‑Base, MACRO, STAT, GRAPH, ACCESS, and MS Office.

Experience with CDISC data standards, e.g., SDTM and ADaM.

Proven experience with Unix and Windows operating systems.

Understanding of the software development life cycle.

Understanding of FDA guidelines.

Good organization, time management, and attention to detail skills to work in a stressful environment under tight deadlines while maintaining focus on details and quality.

Applies good judgment and demonstrates initiative to resolve issues.

Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Information Technology

Industries: Biotechnology Research and IT Services and IT Consulting

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