Clinical Statistical Programmer

About the Role

Now Hiring: ADaM/TLF & FDA Submission Expert.

Location: Hybrid as needed, 2 days/week in Seattle, WA.

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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Why Join?

• Work on cutting-edge AI solutions transforming clinical trial data and regulatory submissions.
• Collaborate with a leading Fortune 500 technology company.
• Flexible part-time engagement with a highly specialized, high-impact project.
• Opportunity to shape the future of AI in clinical research and regulatory compliance.

Pay

The salary for this position is between $150,000 - $160,000 annually. Factors which may affect pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Benefits

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, long-term disability insurance, short-term disability insurance, personal days accrued each calendar year (meets paid sick and safe time laws that pertain to the City/State), 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, and Tuition Reimbursement Program.