The Clinical SAS Programmer will lead the programming activities for various purposes including SAS Data Listings to be used for data review, Safety Review Listings, Centralized Monitoring Listings and Reports. The Clinical SAS Programmer will also be responsible for production of Key Risk Indicators, working collaboratively across departments to produce quality deliverables within agreed timelines and budget, and assists with development and maintenance of optimal strategies to increase productivity and quality, while decreasing cycle times and costs. In addition, the programmer is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Indero's commitment to sponsor's requirements and timelines.
More specifically, the Clinical SAS Programmer must:
Create SAS Data Review Listings, based on protocol, EDC Database and Data Validation Specs.
Create a library of SAS Data Review Listings.
Create Safety Review Listings.
Actively participates in creating reports and listings to support Centralized Monitoring.
Document changes to SAS code, programs, 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.
Requirements:
A Bachelor of Science degree is required;
Master's degree in Computer Science, Information Technology Systems, Statistics, Engineering, or a related field, an asset;
3 to 5 years of clinical research experience in the biotechnology, pharmacy or CRO industry, including 3 years of SAS programming;
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.
Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
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