The Senior Clinical Data Analyst (Sr. CDAn) is capable of leading Clinical Data Analyst programming activities with minimal support and oversight. The Sr. CDAn is capable of creating, leading, and driving activities to assess and improve the Analytics and Reporting programming infrastructure.
Programs metrics and reports in a data visualization tool/analyst software (e.g., Power Business Intelligence (BI), Spotfire).
Ability to independently develop innovative and complex reports to support activities including, but not limited to, data review and surveillance.
Develops and maintains the Analytics and Reporting Global Library to ensure consistency across programs and studies and concordance with the Electronic Data Capture (EDC) Global Library.
Trains Clinical Data Managers and Clinical Data Scientists on how to generate output (e.g., data review tool, metrics).
Works with Clinical Data Manager, Lab Data Specialist, Medical Monitor, and Protocol Lead (and other study team members as appropriate) to develop new or improve existing data review tools.
Coordinates with Clinical Data Managers and Clinical Data Scientists regarding timelines and deliverables to ensure all reports are working as expected.
Mentors less proficient Clinical Data Analysts as appropriate.
Independently manages processes and applications while evaluating for improvements; lead working groups to develop and implement new processes and applications.
May contribute to the development, review and implementation of Standard Operational Procedures (SOPs), templates and processes and other departmental and/or cross functional initiatives.
Utilizes experience and leadership skills to provide guidance to other team members. Takes ownership of process resources available to team.
Complies with required training curriculum.
Completes timesheets accurately as required.
Submits expense reports as required.
Updates CV as required.
Maintains a working knowledge of and complies with company processes, ICH-GCPs and other applicable requirements.
5-10 years of experience with Analyst software (e.g., Spotfire, Power BI, Tableau), preferably in the pharmaceutical or biotechnology industry.
Technical expertise in database and report development.
Experience with programming languages (e.g., Structured Query Language (SQL), Python).
Experience in managing projects as well as effective verbal and written communication skills.
Ability to work independently, organize tasks, time and priorities, ability to multitask.
Knowledge of and experience with clinical databases, electronic data capture systems, quality control processes and auditing procedures.
Strong critical thinking skills.
Familiarity with Good Clinical Practice (GCP), International Council of Harmonization (ICH), and Food & Drug Administration (FDA) requirements as they apply to clinical data.
Strong well-rounded technical skills (EDC systems, Microsoft Word, Excel, PowerPoint).
Regular interaction with Regional Clinical Trial Operations and Medical Management groups.
Regular interaction with other groups within Clinical Data Management, including Clinical Data Programmers, EDC Programmers, and Data Scientists.