Lead Statistical Programmer for Clinical Submissions

Cytel; Trenton (NJ); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel, fully embedded with a global pharmaceutical client, seeks a Principal Statistical Programmer to lead programming for multiple studies. You will deliver SDTM/ADaM datasets, define.xml, listings and complex graphs, while guiding junior programmers and ensuring regulatory readiness.

Ideal candidates have 9+ years in biotech/pharma programming, expert SAS and R skills, CDISC standards mastery, and a proven ability to work independently within a client-facing environment.

Qualifications

• Bachelor's degree in CS, data science, mathematics or statistics.
• 9+ years of experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS/R programming skills in a clinical development environment.
• Extensive CDISC SDTM/ADaM and Define.xml experience.
• Experience supporting regulatory submissions with FDA/ICH guidance.
• Ability to work independently and lead teams.
• Outstanding written and verbal communication skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and Define.xml files for multiple studies.
• Understand and follow FDA regulations affecting reporting of clinical trial data; support FDA submissions.
• Lead and support development of SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and maintain SAS/R programs.
• Oversee programming deliverables for multiple studies to meet timelines.
• Assist in preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Contribute to standards for programming tools, outputs, and macros.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and development partners to meet timelines.

Skills

SAS programming

R programming

Leadership

Communication

CDISC SDTM/ADaM

Education

Bachelor's degree in CS/Math/Stats

Tools

SAS

R

Define.xml

Job description

Cytel, fully embedded with a global pharmaceutical client, seeks a Principal Statistical Programmer to lead programming for multiple studies. You will deliver SDTM/ADaM datasets, define.xml, listings and complex graphs, while guiding junior programmers and ensuring regulatory readiness.

Ideal candidates have 9+ years in biotech/pharma programming, expert SAS and R skills, CDISC standards mastery, and a proven ability to work independently within a client-facing environment.