Role Responsibilities

• 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.
• Delivers data analysis reporting operational services to GBDM and other groups within Pfizer
• Supports business reporting solutions for GBDM inclusive of presenting and communicating results that improve performance
• Servers as Subject Matter Expert (SME) within the team, take ownership of reporting processes within DMRA and serve as mentor to other team members as needed.
• Directly supports knowledge development of Reporting analyst on reporting and analytics tools that support the accuracy and integrity of study data
• Develops innovative, advanced new concepts that improve processes, products across own and related disciplines
• Drives process improvements, global initiatives and change management
• Recognizes development needs and identifies/creates development opportunities within team
• 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 CDS deliverables
• Manages work done by people within a matrix but may have responsibilities as a people manager in select cases
• Directly supports knowledge development of others on reporting and analytics tools that support the accuracy and integrity of study data
  
  

Qualifications

• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field with a minimum of 10 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.)