Principal Statistical Programmer - FDA Submissions Lead

Cytel; Columbia (SC); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel invites a Principal Statistical Programmer to join sponsor-dedicated work with a global pharmaceutical client. You will work independently on SDTM/ADaM deliverables, support FDA submissions, and lead programming activities across multiple studies.

You will contribute to standards, mentor team members, and collaborate with CROs and partners to ensure timely, high-quality outputs. Strong SAS/R skills and CDISC knowledge are essential.

Qualifications

• At least a 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 and R programming skills for clinical programming procedures.
• Extensive CDISC SDTM/ADaM experience, Define.xml and medical terminology knowledge.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to deliver high-quality programming results independently and with leadership.

Responsibilities

• Generate SDTM, ADaM specifications and datasets for multiple studies.
• Develop SAS programs to create listings, tables, graphs and datasets.
• Deliver regulatory-grade programming and ensure timelines.
• Lead and mentor other programmers and oversee deliverables.
• Prepare clinical study reports, regulatory submissions and DSUR analyses.
• Contribute to standards for tools, outputs and macros.
• Collaborate with CROs, vendors and internal teams to meet goals.

Skills

Independent work

Leadership

Excellent communication

FDA/ICH regulatory knowledge

Clinical development experience

CRO collaboration

Education

Bachelor’s degree in computer science / data science / math / statistics

Tools

SAS

R

Define.xml

CDISC SDTM/ADaM

Unix/Linux

Git

Job description

Cytel invites a Principal Statistical Programmer to join sponsor-dedicated work with a global pharmaceutical client. You will work independently on SDTM/ADaM deliverables, support FDA submissions, and lead programming activities across multiple studies.

You will contribute to standards, mentor team members, and collaborate with CROs and partners to ensure timely, high-quality outputs. Strong SAS/R skills and CDISC knowledge are essential.