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924# Statistical Programmer/Analyst III (Permanent role)_Hybrid @ Mississauga, Ontario

Statistical Programmer/Analyst III role at ClinChoice in Mississauga.
ClinChoice
Remote
Hybrid
On-Site
Canada
Undisclosed salary
Job Description
ClinChoice is seeking a Statistical Programmer/Analyst III to join their team in Mississauga, Ontario. This is an advanced-level position where the individual will contribute to making a difference in people's lives through clinical research.

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.

Benefits:
  • ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.
  • Remote work is possible.
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ClinChoice

ClinChoice is a global provider of regulatory and scientific services, specializing in preparing and submitting compliant Material Safety Data Sheets (MSDS/SDS). The company supports multinational chemical manufacturing companies, offering hazard analysis, SDS authoring, and regulatory compliance expertise across US, EU, and other international markets. ClinChoice focuses on establishing structured processes for SDS preparation, and delivers comprehensive hazard assessments and SDS phrases based on global regulatory standards. They provide mentorship and review services.

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