924# Statistical Programmer / Analyst III (Permanent role) Hybrid at Mississauga, Ontario, Canada

ClinChoice; Mississauga; Hybrid; CAD 85,000 - 110,000; Full time

Job summary

A global CRO is seeking a Statistical Programmer / Analyst III in Mississauga. The role involves developing datasets and submission packages for clinical trials. Candidates should have significant programming experience with SAS and a background in statistics or a related field. This position offers a permanent contract with a focus on work-life balance and a collaborative culture.

Qualifications

• At least 5 years of clinical programming experience.
• Proficient in programming logic and able to explain to team members.
• Detail-oriented and adaptable to changes.

Responsibilities

• Annotate Case Report Forms following guidelines.
• Develop SDTM and ADaM datasets using SAS.
• Create electronic submission packages for FDA.

Skills

SAS

C/C++

Python

R

SQL

Artificial Intelligence

Machine Learning

Microsoft Office Suite

Education

Bachelor's/Master's degree in Statistics or related field

Job description

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

Join to apply for the 924# Statistical Programmer / Analyst III (Permanent role)_Hybrid @ Mississauga, Ontario role 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 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 :

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

Employment type: Contract

Job function: Research, Analyst, and Information Technology

Industries: Pharmaceutical Manufacturing

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