Manager - Data Standards, SDTM Programming (Hybrid) (Clinical Data)

Location: Hybrid role in Irvine, California, United States

Salary: $109,500–$208,500 per year

Company

hirify.global develops medicines and solutions across therapeutic areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Develop and govern data collection, data review, SDTM mapping, ADaM, TLF, and safety analysis standards for clinical trial programs.
• Ensure consistency across eCRF, SDTM, ADaM, and reporting standards, documenting assumptions and decisions.
• Provide feedback on CRF design, SDTM datasets, and SDTM Trial Design Domains to support regulatory compliance.
• Program SDTM datasets and oversee the creation of define.xml, annotated CRFs, and Clinical Study Data Reviewers Guides.
• Consult on SDTM and ADaM conformance issues and coordinate resolution with study teams.
• Develop training materials, communicate standards activities, and contribute to industry standards initiatives.

Requirements

• MS degree and 8 years of relevant clinical research experience, or BS degree and 10 years of relevant clinical research experience.
• Experience with SDTM programming is required.
• Experience leading standards development for data collection, tabulation, analysis, or reporting.
• Experience preparing SDTM or ADaM datasets and documentation for regulatory submissions.
• Knowledge of CDISC standards, including CDASH, SDTM, and ADaM, and related regulatory requirements.
• Availability for a hybrid role in Irvine, California, United States.

Nice to have

• CDASH experience.
• Experience with ADaM, Analysis Results Metadata, or TLF standards.
• Active participation in CDISC teams.

Culture & Benefits

• Paid time off, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.
• Environment focused on innovation, integrity, and improving patient outcomes.