925# Statistical Programmer/Analyst II (Permanent role)_Hybrid @ Mississauga, Ontario

ClinChoice is seeking a Statistical Programmer/Analyst II to join their team in Mississauga, Ontario. This is a permanent, hybrid role where the individual will contribute to a quality-focused and collaborative environment.

About 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.

Responsibilities:

• Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
• Develop SDTM specifications and generate SDTM datasets using SAS.
• Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
• Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
• Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
• Analyze information and develop innovative solutions to programming and data analysis challenges.
• Actively communicate with statisticians for statistical input and analysis interpretation.
• Follow and reinforce regulatory agency requirements during daily job.
• Serve as a programming team lead and contribute to department initiative.
• Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
• Review draft and final production deliverables for project to ensure quality and consistency.

Requirements:

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 5 years of clinical programming experience.
• Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
• Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
• Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
• Detail-oriented and ability to learn and adapt to changes.
• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

The role offers:

• Opportunity to make a difference in peoples’ lives.
• Fulfilling and rewarding career.
• Work-life balance.
• Collaborative “one-team” culture.