Clinical Outcomes Solutions

Software Engineer

• Providing support to the Epidemiology team by preparing Real World data, advising on data analytic strategies, and supporting stakeholders in various epidemiology analytic activities
• Programming and conducting statistical analysis under the direction and supervision of epidemiologists/statisticians including data coding, creation of algorithms, linkage of datasets, and use of statistical packages or platforms
• Supporting statistical programming to generate innovative means of data standardization, visualization, and reporting of observational data
• Supporting Medical Affairs (e.g. observational studies leveraging RWD); Global Patient Safety and Risk Management (e.g., analysis to obtain background rates) for the development of regulatory/safety documents, and Clinical Development (e.g.; assessment of patient populations/ protocol feasibility)
• The position will partner with Epidemiologists to manage relationships with internal and external stakeholders
• Being able to prioritize and manage work across multiple projects and stakeholders
• Providing strong communication to ensure successful and timely project delivery
• Solving technical problems with experience and expertise

Principal Statistical Programmer – FSP, RWD/EPI

Vice President

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Executive Consultant – Vice President, Quantitative Clinical Pharmacology

Medical Billing and Coding

• Perform complex medical coding for adverse events, medical history, procedures, and concomitant medications using MedDRA and WHODrug dictionaries.
• Review and validate coding performed by other coders to ensure consistency and accuracy.
• Identify ambiguous or unclear terms and query clinical sites for clarification.
• Maintain coding conventions and ensure alignment with study-specific and sponsor requirements.
• Conduct ongoing coding checks during data cleaning cycles and prior to database lock.
• Participate in the resolution of coding discrepancies, queries, and coding-related data issues.
• Review safety data for coding accuracy in collaboration with medical monitors and safety teams.
• Assist in the preparation of coding-related metrics, reports, and quality documentation.
• Participate in vendor oversight activities when coding tasks are outsourced.
• Stay current with updates to MedDRA and WHODrug dictionaries and communicate relevant changes to project teams.
• Work closely with clinical data management to ensure proper term collection and standardization.
• Partner with safety teams to support expedited reporting, signal detection, and regulatory submissions.
• Support biostatistics and medical writing with queries related to coded terms for analyses and study reports.

Medical Coder

• Collaborates with QuantSci teams to understand requirements and develop processes, tools and utilities that will improve quality and efficiency
• Develops reusable and robust macros and/or utilities, along with detailed training/documentation
• Partners with study teams in use and further improvement of processes and tools
• Promotes technical innovation to drive the development of data analysis and visualization solutions within a clinical data environment
• Participates on QuantSci data and analytics systems strategy and/or technical development initiatives including systems and technology integration, data sharing, analysis, transfer/access and storage platforms or utilities
• Collaborates with Clinical Development Operations, IT and other functional team members to ensure organizational effectiveness / efficiencies from systems and technology platforms
• Facilitates change management activities and training for QuantSci systems and processes

Principal Statistical Programmer – Tool, Macro, Utility Development

Business Analyst

• Supports cross-functional study team and RBQM Leads in Protocol Risk Assessment, risk identification, and evaluation into Risk MAP.
• Support RBQM Leads in selection and implementation of Key Risk Indicators (KRIs), and Quality Tolerance Limit parameters (QTLs) and other applicable assessments and dashboards, conducting end of trial summarization of risk management activities for inclusion to Clinical study report.
• Drafts and oversee RBQM system set up specifications.
• Perform the execution and review of the Study’s assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks.
• Raise signal and issues in RBQM systems and raise actions as appropriate in RBQM system.
• Delivers timely high-quality analytics and supporting RBQM leads in communication to the cross-functional study team to identify resolution.
• Collaborate with assigned programmer to implement study-specific KRIs, QTLs, visualizations, and other analytics in the RBQM system.
• Perform QC study setup in RBQM system vs RBQM system specifications, if required.
• Act as RBQM programmer on set up of KRIs, QTLs, data quality assessments as well as visualizations in the RBQM system, if required.
• Perform the maintenance of the Risk-Based Quality Management (RBQM) system based on RBQM Plan requirements, data sources and structure.
• Ensure appropriate status and process documentation are produced and maintained during the study.
• Communicate and/or escalate serious risks and issues to the RBQM Lead, study team and/or management and Quality, as needed.
• Ensure inspection readiness for clinical risk management and centralized monitoring activities.

Principal Statistical Programmer – FSP, RWD/EPI

Executive Consultant – Vice President, Quantitative Clinical Pharmacology

Medical Coder

Principal Statistical Programmer – Tool, Macro, Utility Development

Clinical Insights Analyst I