Clinical Statistical Programmer

Ascendion is hiring an ADaM/TLF & FDA Submission Expert to support a confidential Fortune 500 technology client developing next-generation AI solutions for clinical trial data and regulatory submissions. This is a unique opportunity for an experienced clinical data professional with deep expertise in ADaM, TLFs, CDISC standards, and FDA submissions to help validate AI-generated clinical trial outputs. You'll work alongside engineering and clinical teams to ensure AI-generated deliverables meet real-world regulatory and submission standards.

Responsibilities

Provide hands-on expertise in ADaM dataset structure and TLF (Tables, Listings & Figures) development; Review and validate AI-generated ADaM/TLF outputs against CDISC standards and FDA submission requirements; Support the preparation and review of FDA submission packages, including Define.xml and associated documentation; Identify compliance gaps, inconsistencies, and submission risks while providing actionable feedback; Partner with engineering and clinical teams to translate regulatory requirements into AI development guidance; Ensure submission-ready data meets quality, compliance, and regulatory expectations

Requirements

Proven hands-on experience building and/or submitting ADaM datasets and TLF packages for clinical trial submissions; Strong knowledge of CDISC ADaM, SDTM, and FDA submission standards; Experience supporting FDA submission packages for clinical trials; Strong analytical, problem-solving, and written communication skills; Ability to review technical outputs and identify regulatory compliance issues

Nice to have

Experience working with AI-assisted clinical data or AI-generated outputs; Experience in GxP-regulated environments; Background in pharmaceutical, biotechnology, or CRO organizations; Experience collaborating with cross-functional teams, including biostatistics, clinical programming, regulatory affairs, and engineering

Benefits

Medical insurance; Dental insurance; Vision insurance; 401(k) retirement plan; Long-term disability insurance; Short-term disability insurance; Personal days accrued each calendar year; 12-15 days of paid vacation time; 6-8 weeks of paid parental leave after a year of service; 9 paid holidays and 2 floating holidays per calendar year; Ascendion Learning Management System; Tuition Reimbursement Program