ROLE SUMMARY

It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. You will play an important role in processing, reviewing, and receiving patient data and records. You will ensure that accurate, timely, and consistent clinical data reaches the medical department and other groups.

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Integrity Senior Analyst, Data Surveillance is responsible for the collection, documentation, and analysis of data to assess the quality, meaning and integrity of the data. This role will be responsible for the timely and high-quality development and delivery of advanced analytics and statistical solutions to identify and interpret patterns and trends in complex datasets.

As a Senior Analyst Clinical Data Integrity, you will act as a “data detective” and analyze and report trends and predictions using relevant data and work across functional lines to identify process improvement opportunities and data governance strategies. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies including data modeling and exploratory data analysis. It is your dedication and focus that will help make Pfizer ready to achieve new milestones and help patients across the globe.

ROLE RESPONSIBILITIES

General:

• Assist the manager implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality Data Science & advanced data analytics processes to meet expected quality, integrity, timelines, and deliverables.

• Use various tools such as Power BI, Python, Alteryx, R, SQL, AWS to extract and visualize Operational, Clinical data and Specifications from various information systems.

• Able to independently cleanse and prepare data, assess and analyze data quality and integrity using data mining, statistical tools, data modeling, advanced analytics and visualization techniques

• Able to understand business processes and how they impact data integrity and quality, prepare data for presentation to study teams using reports and dashboards.

• Promote the use of consistent, efficient, and quality processes to meet timelines and deliverables

• Ensure work carried out is in accordance with applicable Standard Operating Procedures (SOPs) and working practices

• Serve as analyst for multiple projects, assuming responsibility for hands on data exploration activities and interact with study team members including Clinical Data Scientist, Central Monitor and Statistician for deliverables to ensure data integrity

• Serve as a technical resource to the study teams and apply accurate algorithms to complex datasets for data integrity exploration, analysis and visualization and provide technical expertise and business process support

• Engage with key study team members to program study level checks and visualizations that could identify potential fraud in clinical trial operations through signal detection practices; identify inconsistent data, data outliers.

• Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity and overall data analytics and data science activities

• Support central monitoring activities including review system outputs, develop and implement data analyses strategies to optimize statistical monitoring efficiency.

• Develop presentations and trainings for business users to increase understanding of Visualization tools, Data Science, analytics and automation within Clinical Data Sciences.

BASIC QUALIFICATIONS:

• Bachelor’s degree or above in a scientific or business-related discipline required; Degree in Informatics, or Computer science, or Statistics, or related business degree with equivalent experience preferred

• 3-5 years’ experienceExtensive knowledge of data analytics and statistical methodology to help organize and analyze data​

• Works independently, receives instruction primarily on unusual situations

• Ability to organize tasks, time and priorities, ability to multi-task

• Ability to communicate with internal & external stakeholders, locally and globally

PREFERRED QUALIFICATIONS:

• Technical proficiency in data mining and exploratory analysis, data models, data visualization tools and hands on experience in programming languages R/R-Shiny/Python/ SQL; AWS, PowerBI/Spotfire

• Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.

• Good understanding of ICH and Regulatory Guidelines

• Routine problem-solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.

• Thorough understanding of clinical data and relevant data standards

• Knowledge of vendor processes

• Demonstrated experience in developing successful partnerships within study teams

• Strong written and oral communication skills, and project management skills

• Ability to present technical information to a non-technical audience

• Proven ability to operate independently.

• Some exposure working across international boundaries and cultures.

• Ability to manage customer expectations.

• Ability to manage work of others in a remote and/or global setting

• CDISC experience highly desirable

• Proficient in using commercial clinical data management systems and/or EDC products

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