Principal Statistical Programmer, FSP (Remote)

Cytel; Salem (OR); Remote; USD 120,000 - 180,000; Full time

Job summary

Cytel invites a highly experienced Principal Statistical Programmer to work embedded with a major pharmaceutical client, backed by Cytel. You will oversee statistical programming for multiple studies, ensure high-quality outputs, and coordinate with CROs to meet timelines while adhering to FDA/ICH guidelines.

This senior role requires leadership, independent work ethic, and strong SAS/CDISC expertise to deliver analyses, reports, and submissions across therapeutic areas.

Qualifications

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

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and validate SAS/R programs for development programs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project timelines.
• Draft SOPs and work instructions related to statistical programming.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulations

Communication skills

Independence

Leadership

Clinical development

Education

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

Tools

R

Python

Unix/Linux

Git

Shiny

Job description

Cytel invites a highly experienced Principal Statistical Programmer to work embedded with a major pharmaceutical client, backed by Cytel. You will oversee statistical programming for multiple studies, ensure high-quality outputs, and coordinate with CROs to meet timelines while adhering to FDA/ICH guidelines.

This senior role requires leadership, independent work ethic, and strong SAS/CDISC expertise to deliver analyses, reports, and submissions across therapeutic areas.