Senior Statistical Programmer - Clinical Trials & Submissions

Cytel; Canada; On-site; CAD 120,000 - 160,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer embedded with one of our pharmaceutical clients. You will work with autonomy on clinical development programs and lead programming activities across SDTM/ADaM and Define.xml.

You will develop and validate SAS and R programs, oversee data deliverables for regulatory submissions, and mentor junior team members while collaborating with CROs and vendors to meet project timelines.

Qualifications

• Bachelor's degree in CS, data science, math, or statistics.
• 9+ years of experience as a Statistical Programmer in biotech/pharma.
• Strong SAS and R programming skills in clinical development.
• CDISC SDTM/ADaM/Define.xml and FDA/ICH regulations.
• Experience supporting regulatory submissions with FDA/global authorities.
• Ability to work independently and deliver on time; strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and maintain SAS/R code.
• Oversee programming deliverables across multiple studies to meet timelines.
• Contribute to study reports, regulatory submissions, and publications.
• Collaborate with CROs, vendors, and partners to meet project goals.
• Create and validate programming standards, tools, and macros.
• Review data transfer specs for external vendors.

Skills

SAS

R

Leadership

Communication

CDISC SDTM/ADaM

Education

Bachelor’s degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Job description

Cytel is seeking a Principal Statistical Programmer embedded with one of our pharmaceutical clients. You will work with autonomy on clinical development programs and lead programming activities across SDTM/ADaM and Define.xml.

You will develop and validate SAS and R programs, oversee data deliverables for regulatory submissions, and mentor junior team members while collaborating with CROs and vendors to meet project timelines.