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 relevant assumptions
• Ensuring consistency across standard types (e.g., eCRF standards align with TLF standards, SDTM
• Develop training materials to the organization on the proper use of standards in pipeline
• Communicate ongoing standard development activities across the organization.

🎯 Requirements

• MS with 8 years of relevant clinical research experience, or
• BS with 10 years of relevant clinical research experience
• 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

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick),
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Long-term incentive programs
• Competitive compensation range based on geographic location