Manager - Data Standards, SDTM Programming (Hybrid)

📋 Description

• Actively participating with a cross-functional team of subject matter experts to define data
• Participating in a cross-functional team to define ADaM mapping and derivation, study-level
• Ensuring each standard is clearly defined with appropriate documentation of assumptions and
• Ensuring consistency across standard types (e.g., eCRF with TLF, SDTM with ADaM).
• Developing training materials on proper use of standards in pipeline activities.
• Communicating ongoing standard development activities across the organization.

🎯 Requirements

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

🎁 Benefits

• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).
• Eligibility for long-term incentive programs.