AD Data Standard / Stat Programming (Contract)

Associate Director, Data Standards & Statistical Programming (Contractor) - Remote (U.S.) | 12-month | $90–$100/hr • NO C2C • About the Role Our client, a precision-oncology company, is seeking an Associate Director to lead Data Standards & Statistical Programming across multiple oncology programs. You’ll own program-level planning, CDISC implementation, CRO coordination, and regulatory submission deliverables. This is a contract role with our client (not a role at GQR). What You’ll Do • Lead program/study statistical programming strategy and timelines. • Implement and govern CDISC SDTM/ADaM standards and traceability. • Build/validate SAS macros; generate SDTM, ADaM, TLFs, Define.xml, P21, and reviewer guides. • Partner with Biostats/DM/CROs; troubleshoot data issues and automate workflows. • Contribute to SAPs, protocols, CRFs, DMPs, edit checks; mentor junior programmers. What You’ll Bring • MS + 12+ yrs SAS programming in Biotech/Pharma (Ph I–III). • 8+ yrs CDISC SDTM/ADaM; oncology expertise incl. RECIST derivations (≥4 yrs). • Submission experience (ISE/ISS; NDA/BLA/MAA). • 4+ yrs in small/mid-biotech; expert SAS/Base/STAT/GRAPH/SQL/ODS/macros. • Nice to have: R/Python. Contract Details • 12-month contractor; remote U.S.; $90–$100/hr.