Remote Principal Statistical Programmer - FSP Lead

Cytel; Lansing (MI); Remote; USD 120,000 - 150,000; Full time

Job summary

Cytel seeks a Principal Statistical Programmer to work embedded with a global pharmaceutical client. You will deliver SDTM/ADaM specifications, create datasets, and generate complex tables and graphs using SAS and R.

You will oversee CROs to ensure high-quality deliverables on multiple studies and support regulatory submissions and reports. You will work with autonomy, lead programming efforts, and adhere to FDA/ICH guidelines.

Qualifications

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills for SDTM/ADaM, Define.xml, and reporting.
• Experience supporting regulatory submissions and FDA interactions.
• Ability to work independently with minimal supervision.
• Strong communication and leadership abilities.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml.
• Develop SAS programs for datasets, listings, tables, and complex graphs.
• Deliver high-quality results and validate SAS/R programs for development programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions, DSURs and analyses.
• Contribute to standards for tools, outputs, and macros.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership/communication

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel seeks a Principal Statistical Programmer to work embedded with a global pharmaceutical client. You will deliver SDTM/ADaM specifications, create datasets, and generate complex tables and graphs using SAS and R.

You will oversee CROs to ensure high-quality deliverables on multiple studies and support regulatory submissions and reports. You will work with autonomy, lead programming efforts, and adhere to FDA/ICH guidelines.