The Senior Statistical SAS Programmer will lead the programming activities for various purposes including Clinical Study Reports, DSMBs, interim analyses, etc. The SAS Programmer will also be responsible for statistical programming of Statistical Analysis Plans (SAP), data lists and charts for CSRs as well as integrated summaries of security and effectiveness, ad hoc analyzes. The programmer will also be conducting CDISC SDTM programming activities for clinical research projects, working collaboratively across departments to produce quality deliverables within agreed project 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 Innovaderm’s commitment to sponsor’s requirements and timelines.

More specifically, the Senior Statistical SAS Programmer will:

• Create Define XML, Define PDFs, and Reviewers Guides.
• Annotate case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.
• Follow standard SDTM migration programming procedures to create standardized data table templates that conform to the Standard Data Tabulation Model (SDTM).
• Write program specifications based on consultations with the biostatistician.
• Prepare datasets following ADaM standards to support efficient generation of clinical trial statistical analyses.
• Convert specifications into SAS code to generate datasets and tables, Listings, and figures outputs.
• 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.

IDEAL PROFILE

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 15 years of clinical research experience in the biotechnology, pharmacy or CRO industry, including 10 years of SAS programming;
• Experience in leading studies an asset;

Knowledge and skills

• Excellent working knowledge of CDISC SDTM implementation guidelines / processes;
• Excellent knowledge of regulatory requirements and the drug development process, particularly electronic data submission requirements;
• Extended exposure to clinical trial data, SAS data, and database specifications;
• SAS certification and / or Advance Programmer experience would be assets;
• Knowledge of XML programming is an asset;
• Very organized and focused on details, with effective project planning and time management skills;
• Strong verbal and written communication skills in English, French language is an asset;
• 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 (some evening availability is required, estimated 2 times per week for meetings with global team)
• Permanent full-time position 
• Ongoing learning and development 

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.