Principal Clinical Data Analyst

Aspire IRB
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SUMMARY OF POSITION: 

The Clinical Data Analyst analyzes clinical trial data using Analgesic Solutions' Central Statistical Surveillance System and Service (QDSS). QDSS is used to look for aberrant signals in data that may indicate a problem that could affect a trial's outcome. The Analyst works with subject matter experts to evaluate the relevance of signals and recommend analysis-driven interventions. The Analyst recommends and implements new tools and processes to improve the analysis pipeline and the visualization of data signals. The Analyst presents data to study sponsors and gathers feedback from them on the results of interventions.

EDUCATION REQUIREMENTS:

QUALIFICATIONS/EXPERIENCE:

  • 3 years’ experience in Clinical Data Analysis
  • Familiarity with clinical data sets, clinical trial protocols, and FDA, ICH, and GCP guidelines
  • Experience working in a clinical setting is highly desired.
  • Thorough understanding of cross-functional clinical processes including data management and biostatistics
  • Knowledge of development environment, classification, analytical and other software
  • Working knowledge of SQL, Python, R, etc., is preferred
  • Experience with data mining and visualization tools such as Tableau, Spotfire, R, etc. is preferred
  • Ability to work in teams and collaborate with others to clarify requirements
  • Strong written and verbal communication skills

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • Identify, manage and analyze aberrant clinical trial data signals from Analgesic Solutions' Quantitative Data Surveillance System (QDSS)
  • Recommend interventions to address any clinically relevant aberrancies, may include collaborating and consulting with subject matter experts.
  • Provide ongoing analysis on data trends and results to improve the efficiency of data management and the algorithms used for analysis
  • Member of the Data Science and Technology group, testing and providing clinical guidance into the development piece.
  • Identify opportunities to innovate and improve product and the company’s capabilities and help drive prioritization of product features.
  • Provide clinical expertise and guidance to all stages of development, from product ideation through architecture, documentation, implementation, testing, and support.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Promote the mission, vision, and values of Analgesic Solutions
  • Attendance and punctuality are essential functions of the position.

TRAVEL REQUIREMENTS: This role may require up 10% travel which may be domestic or international, including overnight and weekend stays as necessary, consistent with project needs and office location.

PHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM.

WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.

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Wayland%2C%20United%20States

Wayland , United States