Associate Director, Group Lead, Data Management Reporting and Analytics

Role Summary

Part of the Clinical Data and Information Sciences (CDIS) group within Clinical Development & Operations (CD&O). The Group Lead is responsible for data collection, documentation and programming of study and asset level data cleaning and monitoring report requirements. This role includes line management responsibilities, collaboration with CDS and SDSA, and accountability for timely, high-quality deliverables across the Pfizer portfolio.

Responsibilities

• Work with CDIS and SDSA roles and cross-functional study teams to create reporting and analytics solutions that support quality and timely delivery of data management reports and visualizations per standards and data review plans.
• Deliver data analysis reporting operational services to CD&O and other groups within Pfizer.
• Support business reporting solutions for CD&O, including presenting and communicating results to improve performance.
• Create and maintain documentation for reports throughout study/asset lifecycles and file appropriately in the Trial Master File.
• Comply with applicable SOPs and work practices.
• Serve on the data standards board and lead implementation and development of data management reporting standards as needed.
• Act as a technical resource to study teams for data visualization and reporting tools.
• Ensure operational excellence in applying standards and develop data cleaning reports to support the data review plan, collaborating with the Clinical Data Scientist to ensure deliverables across CDIS and SDSA.
• Support knowledge development of others on reporting and analytics tools to ensure accuracy and integrity of study data.
• Identify process/product improvements and develop innovative concepts to improve processes across related disciplines.
• Take appropriate risks to achieve results and identify development opportunities within the team; develop a talent base and anticipate development needs.

Qualifications

• Required: Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field with 5‚Äì7 years of relevant experience in pharma/biotech/CRO or Regulatory Agency; OR Master's/doctorate with five or more years of relevant experience.
• Understanding of drug development and data operations required for reporting clinical trial data (data review, study reports, regulatory submissions, safety updates, etc.).
• Understanding of regulatory requirements and data standards; CDISC knowledge/experience preferred.
• Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills.
• Supervisory experience with remote employees.
• Experience managing complex projects and partnering across functional areas.
• Technical skills with relational databases (MS SQL Server, MS Access, or Oracle), SAS and data visualization tools (Spotfire, jReview).
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.).

Education

• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field; or Master's/doctorate with relevant pharmaceutical/biotech/CRO/Regulatory Agency experience.

Skills

• Data visualization and reporting tool proficiency; experience with SQL, Python and other visualization tools (preferred).
• Ability to lead, influence, coach and develop others; strong collaboration across teams.
• Knowledge of data standards and data management practices.

Additional Requirements

• Flexibility to accommodate different time zones within International Units.
• Office-based role involving substantial computer work and presentations; hybrid on-site requirement of about 2.5 days per week.