Job Application for Sr Manager/ Sr Principal Statistical Programmer at ClinChoice

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Manager/Sr Principal Statistical Programmer on a permanent basis.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Responsibilities
This is Senior Manager level position for Statistical Programming. Key responsibilities and skills may include, but are not limited to:
• Programming edit checks for Data Management with SAS.
• Create tables, listings and figures for clinical study report.
• Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.
• Create or QC SDTM specifications and SDTM datasets.
• Create or QC ADaM specifications and ADaM datasets.
• Create or QC define.xml or define.pdf
• Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf)
• Serve as team leader for one/more Programming groups.
• Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group.
• Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables.
• Following industry standards and be a mentor to other Programming leads or managers.
• Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.
• Be a role model for team members.

Qualifications
• Bachelor’s degree in computer science, statistics or related scientific disciplines with 10+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 9+ year of clinical programming experience;
• Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
• Good understanding of clinical drug development process
• Detail oriented
• Strong communication skills and coordination skills
• Good leadership skills

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

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I UNDERSTAND THIS APPLICATION OR SUBSEQUENT EMPLOYMENT DOES NOT CREATE A CONTRACT OF EMPLOYMENT NOR GUARANTEE EMPLOYMENT FOR ANY DEFINITE PERIOD OF TIME.

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Sr Manager/ Sr Principal Statistical Programmer

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