Principal Statistical Programmer - Lead FDA Submissions

Cytel; Lansing (MI); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel seeks a Principal Statistical Programmer to work embedded with a leading pharmaceutical client, backed by Cytel's support. The role emphasizes strategic leadership in statistical programming across multiple studies, with responsibility for SDTM/ADaM, Define.xml, and regulatory submissions.

The candidate will lead SAS/R development, ensure FDA/ICH compliance, mentor junior programmers, and collaborate with CROs and vendors to meet deadlines.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 9+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team
• Exceptional SAS/R programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
• A drive to support immediate delivery demands while helping the organization adopt new technologies, standards, and ways of working.
• Must be able to work independently
• Outstanding communication skills (written and verbal) and strong leadership skills

Responsibilities

• Generating SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Understand and follow FDA regulations which affect the reporting of clinical trial data, with experience supporting multiple FDA submissions across a broad range of programming activities
• Lead and support the development of SAS programs to generate datasets, complex listings, tables, and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
• Participate in overseeing statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

FDA/ICH regulations

Leadership

Communication

Independent work

Education

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

Tools

SAS

R

Unix/Linux

git

Python

Job description

Cytel seeks a Principal Statistical Programmer to work embedded with a leading pharmaceutical client, backed by Cytel's support. The role emphasizes strategic leadership in statistical programming across multiple studies, with responsibility for SDTM/ADaM, Define.xml, and regulatory submissions.

The candidate will lead SAS/R development, ensure FDA/ICH compliance, mentor junior programmers, and collaborate with CROs and vendors to meet deadlines.