ROLE SUMMARY

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Manager, Senior Reporting Analyst is responsible for the documentation and programming of study and asset level data cleaning and monitoring report requirement deliverables supporting the Pfizer portfolio with high quality and timelines. This role involves design, development and maintenance of key data monitoring and validation reports used to review, monitor, validate and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. Responsibilities also includes providing cross functional operational support where needed (e.g., training and mentoring), providing leadership, direction, oversight to Reporting Analyst in the team and accountable for inspection readiness and quality.

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 8+ 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.)

  
LI#PFE

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.