Role:

Now Hiring:

ADaM/TLF & FDA Submission Expert (Part-Time)

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. Key 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. If you have hands-on expertise in ADaM, TLFs, FDA submissions, CDISC, Define.xml we'd love to hear from you!

Salary Range:

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. The Paid time off benefits meet the paid sick and safe time laws that pertains 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] [Tuition Reimbursement Program] Want to change the world? Let us know. Tell us about your experiences, education, and ambitions. Bring your knowledge, unique viewpoint, and creativity to the table. Let's talk! Preferred Skills ADaM DataSets TLF FDA Submisson Job details Job

ID 332608

Job Requirements Senior Biostatistician Location Seattle, Washington, US Recruiter Divya Email About Ascendion Ascendion is a full-service digital engineering solutions company. We make and manage software platforms and products that power growth and deliver captivating experiences to consumers and employees. Our engineering, cloud, data, experience design, and talent solution capabilities accelerate transformation and impact for enterprise clients. Headquartered in New Jersey, our workforce of 6,000+ Ascenders delivers solutions from around the globe. 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