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 tables
• Ensuring each standard is clearly defined with appropriate documentation of assumptions and
• Ensuring consistency across standard types (e.g., eCRF standards align with TLF standards, SDTM
• Developing training materials for proper use of standards in pipeline activities
• Communicating ongoing standard development activities across the organization

🎯 Requirements

• MS with 8 years of relevant clinical research experience
• BS with 10 years of relevant clinical research experience
• Experience with SDTM programming
• 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

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Long-term incentive programs