Senior Statistical Programmer, Clinical Trials & Submissions

Cytel; Frankfort (KY); Remote; USD 120,000 - 150,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a sponsor client in the pharma/biotech space. You will implement reporting and analyses across multiple studies, oversee CRO deliverables, and contribute to regulatory submissions.

You will bring 7+ years of experience, strong SAS programming skills, and deep knowledge of SDTM/ADaM, Define.xml, and FDA/ICH guidelines. Independence, leadership, and clear communication are essential.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team.
• Exceptional SAS programming skills and experience with CDISC standards (SDTM/ADaM/Define.xml).
• Extensive experience with CDISC standards and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and lead when needed.
• Excellent written and verbal communication and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs.
• Oversee CRO’s programming deliverables to meet timelines.
• Support the preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Comply with FDA regulations and GCP for submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.

Skills

Independent work

Leadership

Communication skills

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 work embedded with a sponsor client in the pharma/biotech space. You will implement reporting and analyses across multiple studies, oversee CRO deliverables, and contribute to regulatory submissions.

You will bring 7+ years of experience, strong SAS programming skills, and deep knowledge of SDTM/ADaM, Define.xml, and FDA/ICH guidelines. Independence, leadership, and clear communication are essential.