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 has responsibilities for the collection, documentation and programming of study and asset level data cleaning and monitoring report requirements. The Data Management and Reporting Analyst will have responsibilities for the timely and high quality development and delivery of reporting solutions supporting the Pfizer portfolio.
- Creates reporting and analytics solutions with appropriate oversight 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 as a technical resource to the study teams for data visualization and reporting tool
- Collaborates with other analysts, Clinical Data Scientists and other roles as needed to apply standards and to develop data cleaning reports to support of the data review plan
- 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 3-5 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory agency.
- Awareness 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.)
- Awareness of regulatory requirements and relevant data standards (CDISC knowledge and experience are preferable)
- Demonstrates strong verbal and written communication skills including ability to communicate remotely
- 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.)