Manager - Data Standards, SDTM Programming (Hybrid)

📋 Description

• Implement the strategy and framework for governance of standards as set by the Head and Associate
• Define data collection standards, data review rules, SDTM mapping within assigned therapeutic areas.
• Participate in cross-functional teams to define ADaM mapping and derivation, study-level tables
• Ensure standards are clearly defined with documentation of assumptions and decisions.
• Ensure consistency across standard types (e.g., eCRF, TLF, SDTM, ADaM).
• Develop training materials on standards usage and communicate standard development activities.

🎯 Requirements

• Minimum qualifications: MS with at least 8 years, or BS with at least 10 years of relevant clinical
• Experience with SDTM programming is required.
• Experience leading the 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

• Comprehensive benefits package including paid time off (vacation, holidays, sick),
• medical/dental/vision insurance,
• 401(k) for eligible employees.
• Eligible for long-term incentive programs.