Data Insights Specialist

Há 4 dias

Rondônia, Brasil beBeeClinical Tempo inteiro

Job Title: Senior Clinical Analyst and Programmer

Job Description:

The Senior Clinical Analyst and Programmer plays a pivotal role in leading programming activities across various domains, encompassing data listings for review, Safety Review Listings, Centralized Monitoring Listings, and Reports. This individual is responsible for gathering and analyzing needs reported by the Data Management and Risk Based Study Management departments, creating code to address these requirements within specified timelines.

This key contributor will assist in developing and maintaining optimal strategies to enhance productivity, quality, while reducing cycle times and costs. Moreover, they are expected to conduct all activities in accordance with applicable regulatory requirements, industry guidelines, and standard operating procedures (SOPs) while respecting our commitment to sponsor's requirements and timelines.

Key Responsibilities:
  • Create listing specifications based on user requirements from DM and RBSM.
  • Develop SAS Data Review Listings, based on protocol, EDC Database, and Data Validation Specs.
  • Establish a library of Manual Data Review Listings.
  • Contribute to the creation of Safety Review Listings.
  • Actively participate in generating reports and listings to support Centralized Monitoring.
  • Document changes to code and specifications.
  • Assist in the development of SOPs related to data standards implementation.
  • Serve as a mentor to junior Analysts and Programmers.
Requirements:Education:
  • A Bachelor of Science degree is required.
  • A Master's degree in Computer Science, Information Technology Systems, Statistics, Engineering, or a related field, is an asset.
Experience:
  • At least 10 years of clinical research experience in the biotechnology, pharmacy, or CRO industry, including 5 years of SAS programming.
Knowledge and Skills:
  • Excellent knowledge of regulatory requirements and the drug development process.
  • Extended exposure to clinical trial data, SAS data, and database specifications.
  • SAS certification and/or Advanced Programmer experience would be assets.
  • Strong verbal and written communication skills in English.
  • Ability to work in a high-speed environment with proven agility to juggle and prioritize multiple competing demands.
Benefits:

Flexible work schedule.

Home-based position.

Ongoing learning and development.

Company Overview:

We strive to create a stimulating work environment that fosters collaboration, innovation, reliability, and responsiveness. Our team is committed to delivering exceptional results and opportunities for growth and development.

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