Senior Biostatistician

About the role

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

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

Responsibilities

• Provide hands-on expertise inADaM dataset structureandTLF (Tables, Listings & Figures)development.
• 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.

Requirements

• 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.
• Able to review technical outputs and identify regulatory compliance issues.

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.

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.

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. 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]