Senior Statistical Programmer (Remote) - SDTM/ADaM Lead

Cytel; Hartford (CT); Remote; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer for a sponsor-dedicated role embedded with a single pharmaceutical client. You will independently drive SDTM/ADaM programming, develop complex datasets, tables, and graphs, and oversee CRO deliverables to ensure high quality and timely submissions.

You will support regulatory submissions, clinical study reports, and DSURs, while adhering to FDA/ICH guidelines.

Qualifications

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

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables with descriptive/inferential stats, and graphs.
• Deliver high-quality programming results, validating and maintaining SAS and/or R programs.
• Oversee CROs' programming deliverables to meet timelines and quality.
• Support preparation of clinical study reports, regulatory submissions, DSURs, and exploratory analyses.
• Ensure compliance with FDA regulations and electronic submission guidelines.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with internal/external stakeholders to meet project goals.
• Draft SOPs and work instructions related to programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

Leadership

Independent worker

Education

Bachelor’s degree in CS/Data Science/Math/Statistics

Tools

R

Python

Unix/Linux

Git

Java

Shiny

Markdown

Job description

Cytel is seeking a Principal Statistical Programmer for a sponsor-dedicated role embedded with a single pharmaceutical client. You will independently drive SDTM/ADaM programming, develop complex datasets, tables, and graphs, and oversee CRO deliverables to ensure high quality and timely submissions.

You will support regulatory submissions, clinical study reports, and DSURs, while adhering to FDA/ICH guidelines.