[Hiring] Clinical Application Specialist III (SAS programming) @Orion Group

Role Description

We are seeking an experienced Senior Clinical SAS Programmer to support safety and efficacy analyses for Immunology clinical programs. This individual will develop and validate ADaM datasets, tables, listings, and figures while supporting Clinical Study Reports and integrated regulatory submissions. The ideal candidate brings extensive clinical SAS programming experience, strong CDISC knowledge, and hands-on expertise translating aCRFs, SDTM data, Statistical Analysis Plans, and programming plans into submission-ready ADaM specifications and datasets.

Key Responsibilities

• Develop ADaM specifications and datasets using aCRFs, SDTM data, Statistical Analysis Plans, and Statistical Programming Plans.
• Support safety and efficacy analyses for Immunology clinical studies.
• Program, review, validate, and quality-check tables, listings, and figures.
• Support Clinical Study Reports and ISS/ISE ADaM programming and submissions.
• Review vendor-generated TLF outputs for accuracy, quality, and compliance with project requirements.
• Serve as a backup clinical programming contact for assigned compounds or projects.
• Ensure programming deliverables meet established quality standards and project timelines.
• Interpret Pinnacle 21 findings and help resolve data-standard or submission-related issues.
• Learn and apply internal SAS macros, programming standards, and established processes.
• Collaborate with statistical programmers, statisticians, data management personnel, vendors, and clinical project teams.

Qualifications

• Approximately 8 or more years of SAS programming experience supporting clinical trial data analysis.
• Extensive hands-on experience developing ADaM datasets and TLF outputs for safety and efficacy analyses.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Demonstrated ability to translate aCRFs, SDTM data, SAPs, and SPPs into ADaM specifications and datasets.
• Experience supporting Clinical Study Reports and ISS/ISE programming and regulatory submissions.
• Experience reviewing and validating internally or externally produced programming outputs.
• Ability to interpret Pinnacle 21 results and quickly learn new macros and programming processes.
• Strong quality focus, attention to detail, communication skills, and ability to meet project timelines.
• Proven ability to collaborate with statisticians, programmers, data management teams, and external vendors.

Preferred Qualifications

• SAS programming experience within a UNIX environment.
• SAS Enterprise Guide experience.
• Immunology therapeutic-area experience.
• Previous experience representing clinical programming within cross-functional clinical project teams.

Benefits

• Medical benefits available at employee cost.