Associate Director - Data Standards (Hybrid)

Location: Hybrid role associated with North Chicago, Illinois and South San Francisco, California, United States

Salary: $141,500–$268,500 per year

Company

hirify.global develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead, manage, and develop a group of clinical data standards experts.
• Develop, implement, maintain, and govern end-to-end data standards from data collection through regulatory submission.
• Review eCRF designs and SDTM conformance mapping specifications for compliance with CDASH and SDTM standards.
• Execute CDISC validation tools, interpret findings, and coordinate resolution and documentation of unresolved issues.
• Manage CDISC metadata, terminology, and standards libraries within the metadata repository.
• Communicate standards concepts across statistical programming, statistics, data science, clinical development, and regulatory functions while mentoring analysts and contributing to CDISC activities.

Requirements

• Bachelor of Science degree.
• 12+ years of relevant clinical research experience, or 10+ years with a master's degree.
• Expert knowledge in at least three areas of clinical data standards and high-level knowledge in at least one additional area, including CDASH, SDTM, ADaM, define.xml, controlled terminology, or metadata management.
• Experience mapping legacy data into SDTM domains for eCTD submissions, including at least two successful CDISC-compliant submissions.
• Knowledge of international regulations and guidance for clinical data standards and regulatory datasets.
• Experience with metadata repository technology, data standards governance, and metadata management.

Culture & Benefits

• Hybrid work environment.
• Paid vacation, 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.