Senior Statistical Programmer, Remote – SDTM/ADaM Expert

Cytel; Salt Lake City (UT); Remote; USD 140,000 - 210,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer for a sponsor-dedicated role embedded with a pharmaceutical client in the United States. The role requires leading complex SAS programming, SDTM/ADaM development, and oversight of CRO programmers to ensure timely, high-quality data outputs for clinical studies.

The ideal candidate will have 7+ years in pharma biometrics, strong FDA/regulatory knowledge, and excellent communication and leadership abilities to drive project success.

Qualifications

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

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides and define.xmls
• Develop SAS programs for datasets, listings, tables and graphs
• Deliver high-quality STAT programming results and maintain SAS/R programs
• Oversee CRO programmers to ensure timely, high-quality deliverables
• Prepare clinical study reports, regulatory submissions and DSURs
• Follow FDA good clinical practice and electronic submission guidelines
• Contribute to standards for programming tools, outputs and macros
• Develop CRFs, edit checks and data validation plans
• Review data transfer specifications for external vendors
• Collaborate with CROs, vendors and partners to meet timelines
• Create SOPs and Work Instructions for programming practices

Skills

Independent work

Leadership

Communication

Education

Bachelors in CS/DS/Math/Stats

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer for a sponsor-dedicated role embedded with a pharmaceutical client in the United States. The role requires leading complex SAS programming, SDTM/ADaM development, and oversight of CRO programmers to ensure timely, high-quality data outputs for clinical studies.

The ideal candidate will have 7+ years in pharma biometrics, strong FDA/regulatory knowledge, and excellent communication and leadership abilities to drive project success.