897#Senior Statistical Programmer Analyst/Permanent role (Hybrid)
Join us for the 897#Senior Statistical Programmer Analyst/Permanent role (Hybrid) at ClinChoice.
About the Role
ClinChoice, a global full-service CRO, is seeking a dynamic Senior Statistical Programmer Analyst to join our in-house team on a permanent basis. This hybrid position is located in Mississauga, Ontario. Be part of a team dedicated to making a difference in people's lives, with a focus on professional development and work-life balance.
Key Responsibilities
- Annotate Case Report Forms following FDA/CDISC or sponsor guidelines.
- Develop SDTM specifications and datasets using SAS.
- Develop ADaM specifications and datasets based on Statistical Analysis Plans.
- Create Tables, Listings, Graphs, and Patient Profiles for clinical reports, posters, and manuscripts.
- Develop ADaM data, Tables, Listings, and Figures for ISS and ISE.
- Create electronic submission packages (e.g., define.xml) following FDA guidelines.
- Analyze data and develop innovative programming solutions.
- Communicate effectively with statisticians and cross-functional teams.
- Ensure compliance with regulatory requirements.
- Serve as a programming team lead, providing guidance and mentorship.
- Review deliverables for quality and consistency.
Qualifications
- Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related fields with at least 5 years of clinical programming experience.
- Proficiency in SAS, C/C++, Java, R, Python, MATLAB, SQL; database programming experience is a plus.
- Strong understanding of programming logic and ability to explain code to team members.
- Knowledge of AI and Machine Learning applications.
- Deep understanding of Good Clinical Practices and regulatory requirements.
- Excellent communication and coordination skills.
- Detail-oriented with adaptability to change.
- Proficient in Microsoft Office Suite.
ClinChoice is an equal opportunity employer committed to diversity and inclusion. We accommodate qualified applicants during the recruitment process upon request. Only shortlisted candidates will be contacted.
Additional Details
- Seniority level: Mid-Senior level
- Employment type: Contract
- Industry: Pharmaceutical Manufacturing