As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Data Management Reporting Analyst (Manager) is responsible for the collection, documentation and programming of study and asset level data cleaning and monitoring report requirements. The Data Management Reporting Analyst (Manager) will be responsible for the timely and high quality development and delivery of reporting solutions supporting the Pfizer portfolio.
- Works closely with department roles and cross-functional study team members to create reporting and analytics solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans.
- Creates any needed documentation for reports throughout the lifespan of the study and or asset for all DMRA deliverables and ensures proper filing in the Trial Master File filings when appropriate.
- Complies with applicable SOPs and work practices
- Serves on the data standards board as needed, and leads as needed implementation and where needed development of data management reporting standards.
- Serve as a technical resource to the study teams for data visualization and reporting tools
- Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables
- Directly supports knowledge development of others on reporting and analytics tools that support the accuracy and integrity of study data
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field w a minimum of five years relevant experience in a pharmaceutical, biotech, CRO, or Regulator Agency with an emphasis on building reporting and analytics solutions.
- Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)
- Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable
- Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills
- Technical skills and experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)
- Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)