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Niche senior clinical SAS and ADaM expertise reduces applicant competition significantly.
Clinical trial and CDISC-specific skills are highly domain-specific and not easily transferable across industries.
Explicit 8+ years, mandatory Clinical SAS/ADaM/CDISC skills and leadership make filters highly strict.
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Develop and validate ADaM and TLF programming outputs using SAS according to statistical analysis plans and specifications.
Lead statistical programming activities including managing multiple concurrent projects, directing other programmers, and ensuring on-time delivery.
Act as a technical subject matter expert on CDISC standards, contributing to SOP development, mentoring, and conducting compliance reviews of regulatory deliverables.
Minimum 8+ years of experience in Clinical SAS programming including Base SAS, Advanced SAS, and SAS/Macro.
Strong experience in ADaM and TLF programming including ADaM dataset specification and generation.
Experience in client handling and leading clinical study programming tasks.
Knowledge of CDISC standards and clinical trial processes; experience with ISDB-ISS and pooling studies is good to have but not mandatory.
Experienced leader capable of managing multiple programming deliverables and guiding junior team members through mentoring and training.
Strong communicator with ability to handle client interactions and represent programming function in sponsor meetings.
Technical expert in CDISC standards with a track record of developing standard operating procedures and ensuring compliance for clinical trial data submissions.