Senior Statistical Programmer - Clinical Development Lead

Cytel; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

The Cytel Principal Statistical Programmer role is embedded with a leading pharmaceutical client in the Boston area, backed by Cytel’s global support. You will drive end-to-end statistical programming for multiple studies, applying SAS and R to produce SDTM/ADaM datasets, listings and figures with a focus on high quality and timely delivery.

You should have 9+ years of experience in statistical programming in biotech/pharma and a track record of regulatory submissions, FDA interactions, and

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics major preferred.
• 9+ years as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS/R programming skills and expertise in statistical programming procedures.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global authorities.
• Ability to work independently and drive delivery while adopting new tech and standards.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide, and define.xml for multiple studies.
• Lead SAS programs to create datasets, listings, tables, and complex graphs.
• Deliver high-quality statistical programming results and maintain SAS/R programs.
• Support preparation of clinical study reports, regulatory submissions, DSURs, and analyses.
• Oversee programming deliverables to meet timelines across studies.
• Create, maintain, and validate standards for tools, outputs, and macros.
• Collaborate with CROs, vendors, and partners to meet project goals.

Skills

SAS programming

R programming

Leadership

Independent worker

Communication

Regulatory mindset

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Java

Shiny

Job description

The Cytel Principal Statistical Programmer role is embedded with a leading pharmaceutical client in the Boston area, backed by Cytel’s global support. You will drive end-to-end statistical programming for multiple studies, applying SAS and R to produce SDTM/ADaM datasets, listings and figures with a focus on high quality and timely delivery.

You should have 9+ years of experience in statistical programming in biotech/pharma and a track record of regulatory submissions, FDA interactions, and