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

ClinChoice; Mississauga; Hybrid; CAD 80,000 - 100,000; Full time

Job summary

ClinChoice, a leading global full-service CRO, is seeking a Statistical Programmer/Analyst III to join their Mississauga team. The role includes responsibilities like developing datasets and collaborating with global teams to ensure compliance with regulatory requirements. Interested candidates with a strong background in programming and clinical trials are encouraged to apply for this full-time position in a dynamic and inclusive environment.

Qualifications

• 5+ years of clinical programming experience required.
• Proven knowledge in high-level computing languages including SAS, C/C++, Java, R, Python, MATLAB, and SQL.
• Strong understanding of clinical drug development processes.

Responsibilities

• Develop SDTM specifications and generate datasets using SAS.
• Create electronic submission packages to FDA based on guidelines.
• Serve as a programming team lead and mentor team members.

Skills

SAS

C/C++

Java

R

Python

MATLAB

SQL

Artificial Intelligence

Machine Learning

Good Clinical Practices

Clinical trial process

Education

Bachelor’s/Master’s degree in Statistics

Computer Science

Electrical Engineering

Biotechnology

Tools

Microsoft Office Suite

Job description

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

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

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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 Statistical Programmer/Analyst III 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!

Job Summary

This is an advanced-level Statistical Programmer/Analyst III position. Key responsibilities and skills may include, but are not limited to:

• 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.
  
  
  

Qualifications

• 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.
• 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.
• Detail-oriented and ability to learn and adapt to changes.
• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
  
  
  

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 [phone] 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.

#Senior #Contract

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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