Senior Statistical Programmer — Clinical Trials Lead

Cytel; Augusta (ME); Remote; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client. You will lead statistical programming activities across studies, delivering SDTM/ADaM artifacts and high-quality outputs tailored to regulatory submissions.

You will collaborate with CROs and internal teams, ensuring timely delivery and adherence to FDA/ICH guidelines while contributing to the development of standards, documentation, and data validation plans.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills and regulatory submission experience.
• Extensive CDISC SDTM/ADaM/Define.xml knowledge and FDA/ICH familiarity.
• Experience supporting regulatory submissions and interactions with FDA or global authorities.
• Ability to work independently and lead teams with strong communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and Define.xml for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables and graphs.
• Deliver high-quality programming results and validate SAS/R programs for clinical development.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Adhere to FDA/good clinical practice guidelines for submissions.
• Contribute to standards for tools, outputs and macros; draft data validation plans.
• Develop CRFs, edit checks, and data transfer specifications with external vendors.
• Collaborate with CROs, software vendors, and development partners to meet goals.
• Review SOPs and work instructions related to statistical programming.

Skills

SAS programming

CDISC standards

Regulatory submissions

Leadership

Independent work

Communication

Education

Bachelor’s degree in computer science or related

Tools

SAS

R

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client. You will lead statistical programming activities across studies, delivering SDTM/ADaM artifacts and high-quality outputs tailored to regulatory submissions.

You will collaborate with CROs and internal teams, ensuring timely delivery and adherence to FDA/ICH guidelines while contributing to the development of standards, documentation, and data validation plans.