Principal Statistical Programmer – Lead Clinical Data

Cytel; Little Rock (AR); On-site; USD 140,000 - 210,000; Full time

Job summary

The Principal Statistical Programmer role at Cytel places you in a sponsor-dedicated position with a pharmaceutical client, focusing on SDTM/ADaM and extensive SAS/R programming. You will lead programming activities across studies and mentor team members.

You will work with internal and external partners to ensure timely, regulatory-compliant data deliverables and drive high-quality outputs for submissions and publications.

Qualifications

• 9+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS/R programming skills and expertise in development and implementation of statistical programming procedures and processes in a clinical development environment
• Extensive CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
• Must be able to work independently
• Outstanding communication skills (written and verbal) and strong leadership skills

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies
• Understand and follow FDA regulations affecting reporting of clinical trial data, with experience supporting multiple FDA submissions
• Lead and support development of SAS programs to generate datasets, complex listings, tables, and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
• Participate in overseeing statistical programming deliverables for multiple clinical studies to ensure high-quality and meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners) to ensure meeting project timelines and goals

Skills

SAS programming

R programming

Leadership

Education

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

Tools

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

The Principal Statistical Programmer role at Cytel places you in a sponsor-dedicated position with a pharmaceutical client, focusing on SDTM/ADaM and extensive SAS/R programming. You will lead programming activities across studies and mentor team members.

You will work with internal and external partners to ensure timely, regulatory-compliant data deliverables and drive high-quality outputs for submissions and publications.