Description
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.
Requirements
Education
A Bachelor of Science degree is required;
Master's degree in Computer Science, Information Technology Systems, Statistics, Engineering, or a related field, 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 Advance Programmer experience would be assets;
Very organized and focused on details, with effective project planning and time management skills;
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;
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
Flexible work schedule
Permanent full-time position
Ongoing learning and development
About Indero
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Argentina.
Originally posted on Himalayas