Manager, Statistical Programming

The Manager, SAS Programming will be responsible for overseeing and performing the activities conducted by the SAS Programming team. These activities include programming that is required for various purposes such as Clinical Study Reports, DSMBs, interim analyses, Statistical Analysis Plans (SAP), data lists and charts for CSRs as well as integrated summaries of security and effectiveness, or ad hoc analyzes. The Manager SAS Programming will also be overseeing and 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 Manager SAS Programming 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.

This role will be perfect for you if:

• You enjoy managing team members and improving continuously.
• You are a good SAS programmer leader interested in working with a small yet Global team, in a mid-sized company.
• You have a preference for a work environment where you will work on a large variety of programming deliverables.

Responsibilities

More specifically, the Manager, SAS Programming will:

• Provides direct oversight of SAS programming operations, including planning and assigning work, overseeing the performance of direct reports, conducting performance reviews and approving timesheets.
• Ensures adequate training and mentoring of SAS programmers regarding applicable regulatory guidelines, programming practices, and computer systems.
• Responsible for resource allocation in the department.
• 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

• 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 7 years of clinical research experience in the biotechnology, pharmaceutical or CRO industry, including 5 years of SAS programming;
• At least 1 year of supervisory experience or project team lead experience, preferred;

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 French and English;
• Ability to work in a high-speed environment with proven agility to juggle and prioritize multiple competing demands;
• Must be able to work independently as well as part of a team.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

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 the position of Manager, Statistical SAS Programming, you will be eligible for the following perks:

• Permanent full-time position.
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities).
• Ongoing learning and development.

Work location

This position may be based at our headquarters in Montreal, or remote anywhere in Canada.

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 Canada.