Clinical Data Sciences Consultant

at  FHI Clinical Inc

SUMMARY OF THE POSITION:

The Clinical Data Sciences Consultant (CDS Consultant) will provide statistical and programming support, as applicable for clinical projects undertaken by FHI Clinical, in accordance with the relevant trial protocol and other trial-related documentation, ICH GCP (and local adaptions thereof), local legal requirements and relevant FDA, EMA and other international guidelines as well as applicable procedural documents.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Effective oral and written communication skills in English.
• Uncompromising attention to detail, the ability to think analytically, and being a fast learner.
• Organization and planning ability.
• Sound problem-solving and decision-making skills and the ability to work independently.
• Basic clinical knowledge.
• Excellent computer skills and the ability to acquire proficiency with appropriate software packages, languages, and frameworks.
• Good interpersonal skills.
• Proficient knowledge of international and local regulations and guidelines applicable to clinical research.

POSITION REQUIREMENTS:

Education: Bachelor’s degree or higher (or its international equivalent). Science-related field preferred.
Preferred Job-related Experience: A minimum of five (5) years of data science experience is required. Experience in statistical/database/analytical programming, preferably in a clinical research setting, is favorable.
Additional Eligibility Qualifications: None

Special Position Requirements: Experience and proficiency in:

• R, especially the Tidyverse, Shiny and Shiny Manager

TRAVEL REQUIREMENTS:

Expected travel time is less than 10% for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

• Develop programming to examine trends in exported clinical data regarding protocol compliance and subject safety, including producing graphics conveying key metrics.
• Pre-processing and post-processing related to imported and exported data.
• Perform data quality checks.
• Perform quality control review of programs and output.
• Provide clinical data support, as applicable, for clinical projects undertaken by FHI Clinical.
• Communicate with team members regarding biometric programming, trial timelines, data quality, and results interpretation.
• Provide input into/assist various departments and trial teams with:
• Project tracking.
• Improving the efficiency of FHI Clinical processes/activities through automation using open-source tools.
• Produce and deliver on Clinical Science projects:
• 8.1. Idea canvases (as part of facilitating idea generation with primary stakeholders).
• Work with internal and external stakeholders to identify key parameters to be monitored through centralized statistical review.
• Requirement specifications.
• Business cases / proof-of-concepts of projects.
• Develop data tools that address the business needs specified in the user requirements, including appropriate version control and backup.
• Assist in validating data tools, where applicable, including applicable documentation.
• Deployment of developed data tools and maintenance of deployed data tools, including appropriate change control procedures.
• Provide programming support to departments, as required.
• All other duties as assigned.