Senior Statistical Programmer — Clinical Data & Submissions Lead

Cytel; Topeka (KS); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel invites a Principal Statistical Programmer to join a sponsor-dedicated role, fully embedded with one of our global pharmaceutical clients. You will work independently with minimal supervision, shaping data delivery and contributing to FDA submissions.

You will lead SAS/R programming for SDTM/ADaM, define datasets, and mentor team members while collaborating with CROs and vendors to meet study timelines. This client-facing role emphasizes ownership and technical excellence.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 9+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS/R programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions with FDA or global authorities.
• Ability to work independently and lead with strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and Define.xml for multiple studies.
• Lead SAS programs to generate datasets, listings, tables and graphs.
• Develop, validate and maintain SAS and/or R programs for clinical development needs.
• Oversee programming deliverables for multiple studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Create and validate programming standards, tools, and macros.
• Provide data transfer specifications for external vendors when required.
• Collaborate with CROs, vendors and internal teams to meet project goals.

Skills

SAS

R

CDISC SDTM

CDISC ADaM

Define.xml

FDA submissions

Leadership

Communication

Independent work

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Shiny

Java

Job description

Cytel invites a Principal Statistical Programmer to join a sponsor-dedicated role, fully embedded with one of our global pharmaceutical clients. You will work independently with minimal supervision, shaping data delivery and contributing to FDA submissions.

You will lead SAS/R programming for SDTM/ADaM, define datasets, and mentor team members while collaborating with CROs and vendors to meet study timelines. This client-facing role emphasizes ownership and technical excellence.