Manager - Data Standards, SDTM Programming (Hybrid)

📋 Description

• Actively participating with a cross-functional team of subject matter experts to define standards
• Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions
• Ensuring consistency across standard types (e.g., eCRF, TLF, SDTM, and ADaM standards align)
• Developing training materials for the organization on the proper use of standards in pipeline
• Communicating ongoing standard development activities across the organization
• Providing feedback on CRF design and SDTM datasets to support regulatory compliance with CDISC

🎯 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
• Hands-on experience with CDISC standards (CDASH, SDTM, ADaM) preferred

🎁 Benefits

• Comprehensive benefits package including paid time off (vacation, holidays, sick)
• Medical, dental, and vision insurance
• 401(k) plan
• Eligibility for long-term incentive programs
• Remote work flexibility with Tuesday-Thursday onsite and Monday/Friday remote hybrid schedule
• Annual salary range: $109,500 - $208,500 (USD)