Senior Clinical Data Scientist Job Opportunity

Key Responsibilities

The Senior Clinical Data Scientist will:

• Serve as the Functional Lead for Clinical Data Science on complex projects with diverse scopes, acting as the primary contact for internal liaisons between Clinical Data Science, Project Management, Clinical Monitoring, and other functional groups.
• Act as the central steward of clinical data quality, monitoring risks through holistic reviews of clinical and operational data, and ensuring alignment with cross-functional operational plans.
• Identify required data elements and oversee data quality steps to support defined study analysis.
• Communicate and troubleshoot complex data-related questions with assigned project teams, recommending potential solutions, and escalating issues impacting patient safety and study analysis.
• Coordinate cross-functional data cleaning activities to meet quality standards and timelines for clinical data deliverables.
• Develop clinical data acquisition plans and corresponding data flow diagrams for complex studies, assessing risks associated with protocol design and program-level strategies.
• Design and drive the development of analytical tools, utilizing platforms/dashboards to detect unreliable data that may affect trial results.
• Demonstrate an understanding of advanced technology methods and their applicable scopes for studies or programs of studies.
• Perform analytic reviews as defined in scope of work and data acquisition plans, systematically resolving complex data issues.
• Monitor and communicate project progress to sponsors and project teams, utilizing project status reports and tracking tools/metrics.
• Ensure the launch, delivery, and completion of all Clinical Data Sciences activities and milestones per contractual agreements, relevant SOPs, guidelines, and regulations.
• Perform metric collection and data analysis to support continuous process improvement.
• Review budgets, identify out-of-scope Clinical Sciences activities, and coordinate necessary changes with the PM.
• Plan, manage, and request Clinical Data Science resources for assigned projects.
• Coordinate the work of the assigned Clinical Data Science team.
• Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
• Maintain ongoing documentation and ensure up-to-date TMF filing for necessary files.
• Participate in and present at internal, Sponsor, third-party, and investigator meetings on behalf of Clinical Data Science responsibilities.

Qualifications

We are looking for candidates with:

• Clinical Data Science experience or an equivalent combination of education and experience.
• Experience in Clinical Data Science practices and relational database management software systems.
• In-depth knowledge of the drug development process and its impact on data quality, including risk-based approaches and biometric procedures.
• Sound knowledge of analytic modeling methods such as regression, classification, and clustering.
• Strong project management skills and familiarity with project management methodologies.
• Advanced analytical skills and knowledge of artificial intelligence/machine learning methodologies (preferred).
• Demonstrated staff leadership skills.
• Knowledge of ALCOA++ data quality principles.
• Expertise in protocol interpretation, data collection, and data cleaning specification development.
• Experience with data analysis/review and visualization tools including but not limited to Python, R, Spotfire, and SAS.
• Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements, especially those applicable to Clinical Data Sciences.
• Proficiency in MS Windows, Word, Excel, PowerPoint, and email applications.
• Effective oral and written communication and presentation skills.
• Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Flexibility to adapt to change, work independently, and be part of a multidisciplinary team.
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.

How to Apply

If you meet the above qualifications and are interested in joining our dynamic team, please apply through the Lifelancer website:

Additional Information:

• Company Name: Lifelancer