Senior Clinical Analyst and Programmer (India)

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 Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’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 Innovaderm, 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 

Work location

Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.

About Innovaderm 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Innovaderm only accepts applicants who can legally work in India.