Remote Principal Statistical Programmer - FSP Lead

Cytel; Phoenix (AZ); Remote; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to be sponsor-dedicated within a pharmaceutical client project. You will work with Cytel behind the scenes to drive high-quality data summaries and regulatory deliverables across studies.

You will lead SAS/R programming efforts, oversee CRO providers, and ensure adherence to FDA/ICH guidelines while contributing to study reports and submissions. This role requires independence, leadership, and strong data analytics skills.

Qualifications

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in developing statistical programming procedures.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities.
• Ability to work independently and demonstrate strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results, validating and maintaining SAS/R programs.
• Oversee CRO programming deliverables to ensure quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in CRF development, edit checks, and data validation plans.
• Provide data transfer specifications for external vendors.

Skills

SAS programming

Statistical programming

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Education

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to be sponsor-dedicated within a pharmaceutical client project. You will work with Cytel behind the scenes to drive high-quality data summaries and regulatory deliverables across studies.

You will lead SAS/R programming efforts, oversee CRO providers, and ensure adherence to FDA/ICH guidelines while contributing to study reports and submissions. This role requires independence, leadership, and strong data analytics skills.