Senior Clinical Analyst & Programmer - Flexible Schedule

Indero; Buenos Aires; Hybrid; ARS 90,873,000 - 136,310,000; Full time

Job summary

Indero is seeking a Senior Clinical Analyst and Programmer in Argentina to lead programming activities for data listings, safety reviews, and centralized monitoring. The role involves gathering needs from DM and RBSM, creating SAS listings, and ensuring compliance with regulatory standards and Indero SOPs.

You will mentor junior staff, develop new listings and reports, and drive productivity while maintaining quality and adherence to timelines and budgets.

Qualifications

• Experience creating SAS Data Review Listings based on protocol, EDC Database and Data Validation Specs.
• Ability to gather user requirements from DM and RBSM and translate into validated listings and reports.
• Familiarity with regulatory requirements and Indero SOPs.

Responsibilities

• Create listing specifications from DM and RBSM requirements.
• Develop SAS Data Review Listings based on protocol and Data Validation Specs.
• Build a library of Manual Data Review Listings.
• Develop Safety Review Listings for monitoring activities.
• Contribute to Centralized Monitoring reports and listings.
• Document changes to code and specifications.
• Assist in SOP development related to data standards.
• Mentor junior Analysts and Programmers.

Skills

SAS

Data Listings

Regulatory Compliance

Data Management

SOP Development

Mentoring

Job description

Senior Clinical Analyst and Programmer-Argentina

The Senior Clinical Analyst and Programmer will lead the programming activities for various purposes including different data listings to be used for data review, Safety Review Listings, Centralized Monitoring Listings and Reports. The Senior Clinical Analyst and Programmer will be responsible to gather, understand and analyze the needs reported by the Data Management (DM) and Risk Based Study Management (RBSM) departments, and to create code to answer these needs within agreed timelines and budget. This person will assist with development and maintenance of optimal strategies to increase productivity and quality, while decreasing cycle times and costs. In addition, the Senior Clinical Analyst and Programmer is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.

More specifically, the Senior Clinical Analyst and Programmer must:

• Create listing specifications based on user requirements mainly from DM and RBSM.
• Create SAS Data Review Listings, based on protocol, EDC Database and Data Validation Specs.
• Create a library of Manual Data Review Listings.
• Create Safety Review Listings.
• Actively participates in creating reports and listings to support Centralized Monitoring.
• Document changes to code and specifications.
• Assist in the development of Standard Operating Procedures (SOPs) related to the implementation of data standards.
• Assist with development and maintenance of strategies to increase productivity and quality, while decreasing cycle times and costs.
• Serve as a mentor to more junior Analysts and Programmers.