About this role
Job title: Manager, Clinical Database Application and Reporting
About the Role This role sits within the Biostatistics and Data Management team and is focused on clinical database programming and reporting. The Manager, Clinical Database Application and Reporting collaborates with CROs and vendors to deliver high-quality data deliverables for drug development and regulatory submissions, and may lead Clinical Database setup and reporting.
What You'll Do
- Serve as a subject matter expert in clinical database programming and reporting tools (e.g., Spotfire, Business Objects 4.1) to support Biostatistics, Data Management and other stakeholders.
- Oversee the development, maintenance, and compliance of standard reports for clinical studies (Global Objects, CRF modules, external data).
- Develop reports and visualizations in Spotfire to enable holistic data review (e.g., patient profiles, efficacy trends, ad-hoc reports).
- Manage external vendors and ensure accurate, high-quality deliverables.
- Create and maintain specifications for standard reports and visualizations.
- Author SAS programs to generate complex data review listings and reports, ensuring data quality, consistency, and validity.
- Develop and maintain SAS programming standards for ad-hoc and standard listings used in data review.
- Review annotated CRFs and database structures; mentor and train other Data Management associates as needed.
- Participate in SOPs, policies, and guidelines; ensure regulatory compliance and promote innovations in reporting systems.
- Establish and implement programming standards and ensure compliance across studies; review deliverables for quality before sharing with internal or external clients.
What We're Looking For
- Education: Bachelor's degree required; Master's degree preferred.
- Experience: 4+ years in database programming for study design and data validation in EDC; RAVE/Medidata solutions preferred.
- Expertise with reporting tools Spotfire, J-Review, Business Objects 4; SAS preferred.
- Database design and clinical programming experience in biotech/pharma/CRO industry preferred.
- Experience with development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission.
- Knowledge of industry standards: CDISC-SDTM/CDASH preferred.
- Experience with external data handling of study data preferred.