Associate Director, Group Lead, Data Management Reporting and Analytics

ROLE SUMMARY

As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Group Lead is responsible for the collection, documentation and programming of study and asset level data cleaning and monitoring report requirements.  The Group Lead works closely with the Program Lead (Reporting and Analytics) and CDS Therapeutic Area (TA) Leads to ensure the CDS team functions as a harmonized unit with consistent, timely and high quality application of process and delivery of CDS responsibilities. The Group Lead will also support CDS and Statistical Data Sciences & Analytics (SDSA) data deliverables from acquired companies. This role has additional line management responsibilities supporting development, system/technical processes, resources and colleague development. The Group Lead will also be accountable for the timely and high quality deliverables supporting the Pfizer portfolio.

ROLE RESPONSIBILITIES

• Works closely with CDIS and SDSA 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 CD&O and other groups within Pfizer
• Supports business reporting solutions for CD&O inclusive of presenting and communicating results that improve performance
• 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 CDIS and SDSA deliverables
• Directly supports knowledge development of others on reporting and analytics tools that support the accuracy and integrity of study data
• Identifies existing process/product improvements
• Develops innovative, advanced new concepts that improve processes / products across own and related disciplines
• Takes appropriate risks to achieve desired results
• Recognizes development needs and identifies/creates development opportunities within own team
• Develops a talent base and anticipates development needs within the area of responsibility

BASIC QUALIFICATIONS

•  Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field with 5 to 7 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency OR  Masters or doctoral degree w  Five or more years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
• 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), leadership, decision-making, influencing, negotiation, and project management skills
• Supervisory experience required with emphasis on managing employees remotely located
• Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas
• Technical skills and experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle), SAS and data visualization tools (e.g. Spotfire, jReview)
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

PREFERRED QUALIFICATIONS

• Preference provided to those with programming, specifically SQL, Python and other visualization tools hands-on experience
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

• Flexibility to accommodate different time zones within International Units
• Primarily an office-bas