Statistical & Clinical Data Management Programmer II
Tasks
- Analyze user requirements for study builds
- Assist with CRF builds
- Assist with preparation and review of SOPs and work instructions
- Coordinate external partners EDC vendors and collaborators
- Coordinate programming operations using statistical methodologies
- Design implement and document programs and database applications
- Ensure data structures comply with FDA ICH and CDISC standards
- Facilitate communication across biostatisticians data managers and clinical stakeholders
- Generate analytic datasets
- Generate data dictionaries and variable specifications
- Generate program data review listings
- Generate tables listings and figures for FDA DSMB reporting
- Maintain user access requests on EDC databases
- Participate in data management and analysis meetings
- Perform program quality control and documentation
- Provide database and statistical programming support for clinical studies
- Support development of clinical study databases
- Validate study outputs
Perks/Benefits
- 403b
- Dental insurance
- Life insurance
- Medical insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
ADaM | Advarra | CDISC | CRF | Data Validation | Data dictionaries | EDC | FDA Regulations | ICH Guidelines | Medidata Rave | Microsoft Access | R | SAS | SDTM | Variable Specification
Education
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