Manager - Data Standards, SDTM Programming (Hybrid)

📋 Description

• Participating in a cross-functional team of subject matter experts to define data collection
• Participating in the definition of ADaM mapping and derivation standards, study-level
• Ensuring standards are clearly defined with appropriate documentation of assumptions and decisions
• Developing training materials for the organization on proper use of standards in pipeline
• Communicating ongoing standard development activities across the organization.
• Providing feedback on CRF design and SDTM datasets to ensure compliance with CDISC standards

🎯 Requirements

• MS with 8 years of relevant clinical research experience, or BS with 10 years.
• Experience with SDTM programming is required.
• Experience leading development of standards for data collection, tabulation, analysis and/or
• Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.
• Experience with CDASH is highly recommended.
• Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful.

🎁 Benefits

• Base pay range: $109,500 - $208,500 (actual based on geographic location).
• Comprehensive benefits package including paid time off, medical/dental/vision insurance, 401(k).
• Long-term incentive programs.
• Hybrid work schedule: Tuesday-Thursday onsite, Mondays & Fridays remote.