Senior Statistical Programmer, FSP — Remote

Cytel; Jackson (MS); Teletrabalho; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

The Principal Statistical Programmer at Cytel will be embedded with a sponsor client and drive programming deliverables for multiple clinical studies. You will lead SAS-based data creation, SDTM/ADaM specifications, datasets, and define.xml, and oversee CRO programmers to ensure timely, high-quality outputs.

You will work under the Director, Biostatistics and Programming, applying CDISC standards, supporting regulatory submissions, and contributing to study reports, DSURs, and exploratory

Qualificações

• Bachelor’s degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and experience with clinical development programming procedures.
• Extensive experience with CDISC SDTM/ADaM standards and FDA/ICH regulation.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and lead.
• Outstanding written and verbal communication and leadership skills.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality programming results and maintain SAS/R programs for clinical programs.
• Oversee CROs’ programming deliverables to meet timelines and quality.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.

Conhecimentos

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

git

communication skills

leadership

Formação académica

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

Ferramentas

CDISC SDTM

CDISC ADaM

Define.xml

Descrição da oferta de emprego

The Principal Statistical Programmer at Cytel will be embedded with a sponsor client and drive programming deliverables for multiple clinical studies. You will lead SAS-based data creation, SDTM/ADaM specifications, datasets, and define.xml, and oversee CRO programmers to ensure timely, high-quality outputs.

You will work under the Director, Biostatistics and Programming, applying CDISC standards, supporting regulatory submissions, and contributing to study reports, DSURs, and exploratory