Clinical Statistical Programmer

Ascendion; Seattle (WA); Hybrid; USD 150,000 - 160,000; Part time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) retirement plan

Parental leave

Paid vacation

Job summary

Ascendion is hiring an ADaM/TLF & FDA Submission Expert to support a Fortune 500 technology client. The role focuses on regulatory compliance for AI-generated clinical trial data, with emphasis on ADaM, TLFs, CDISC standards, and FDA submissions.

The position offers a flexible part-time engagement, hybrid work in Seattle, WA, and collaboration with cross-functional teams including biostatistics and regulatory affairs to ensure submission-ready data.

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.

Responsibilities

• 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.

Skills

ADaM datasets

TLF packages

CDISC ADaM

SDTM

FDA submission standards

Regulatory compliance

Regulatory writing

Job description

Ascendion is an AI-native software engineering disruptor helping businesses innovate faster, smarter, and with greater impact. We partner with enterprise clients across North America, the UK, Europe, and APAC to solve complex challenges in data, experience design, software product engineering, and workforce transformation. Powered by expert engineers, thousands of AI agents, and our Engineering to the Power of AI (EngineeringAI) method, we deliver measurable outcomes that build trust, unlock value, and accelerate growth.

Learn more at https://ascendion.com/.

Engineering to the Power of AIℤ, AAVAℤ, EngineeringAI, Engineering to Elevate Lifeℤ, Enterprise PlatformsAI, Data & InsightsAI, ExperienceAI, GCCAI, OperationsAI, Platform EngineeringAI, ProductAI, and Quality EngineeringAIare trademarks or service marks of Ascendion®. AAVAℤ is pending registration. Unauthorized use is strictly prohibited.

Ascendion | Engineering to elevate life

We have a culture built on opportunity, inclusion, and a spirit of partnership. Come, change the world with us:

• Build the coolest tech for the world’s leading brands
• Solve complex problems - and learn new skills
• Experience the power of transforming digital engineering for Fortune 500 clients
• Master your craft with leading training programs and hands-on experience

Experience a community of change makers!

Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion.

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. Ascendion is built differently to engineer the next.

Ascendion | Engineering to elevate life

We have a culture built on opportunity, inclusion, and a spirit of partnership. Come, change the world with us:

• Build the coolest tech for world’s leading brands
• Solve complex problems - and learn new skills
• Experience the power of transforming digital engineering for Fortune 500 clients
• Master your craft with leading training programs and hands-on experience

Experience a community of change makers!

Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion.

About the Role:

Now Hiring: ADaM/TLF & FDA Submission Expert

Location:

Hybrid as needed 2 days/week in Seattle, WA

Ascendion is hiring anADaM/TLF & FDA Submission Expertto 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 inADaM, TLFs, CDISC standards, and FDA submissionsto 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

• Review and validate AI-generated ADaM/TLF outputs againstCDISC standardsandFDA submission requirements.
• Support the preparation and review ofFDA submission packages, includingDefine.xmland 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 submittingADaM datasetsandTLF packagesfor clinical trial submissions.
• Strong knowledge ofCDISC ADaM,SDTM, and FDA submission standards.
• Experience supportingFDA submission packagesfor clinical trials.
• Strong analytical, problem-solving, and written communication skills.
• Ability to review technical outputs and identify regulatory compliance issues.

Preferred Qualifications

• Experience working withAI-assisted clinical dataor AI-generated outputs.
• Experience inGxP-regulatedenvironments.
• 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-edgeAI solutions transforming clinical trial data and regulatory submissions.
• Collaborate with a leading Fortune 500 technology company.
• Flexiblepart-timeengagement with a highly specialized, high-impact project.
• Opportunity to shape the future of AI in clinical research and regulatory compliance.

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]