SAS Programmer at Clario, developing CDISC-compliant datasets and statistical reports for clinical studies. Supporting internal teams and regulatory submissions in a remote/hybrid role.
Responsibilities
Support statistical programming activities for assigned studies
Create dataset specifications as per study requirements
Develop and maintain SAS code for analysis datasets, including programming analysis-specific flags per Statistical Analysis Plan
Generate CDISC-compliant SDTM and ADaM datasets for clinical trials in coordination with internal teams and clients
Create define.xml and dataset reviewer’s guide for FDA submissions
Assist statisticians in preparing TLFs for clinical studies
Provide programming support for ad-hoc client requests
Participate in process improvement initiatives and mentor new team members
Recommend and implement SOPs for improved procedures within the Statistics group
Requirements
Bachelor’s or Master’s degree in Statistics, Biostatistics, or related field
Minimum 6 years of experience with SAS products and procedures in pharmaceutical or life sciences settings
Experience with CDISC SDTM and ADaM standards
Understanding of pharmaceutical drug development processes
Strong organizational, analytical, and communication skills
Detail-oriented with excellent time management abilities
Ability to work effectively in teams and within a matrix organization
Experience with Windows and Microsoft Office products; TLF generation experience is a plus
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