Senior Statistical Programmer - SDTM/ADaM Lead

Cytel; Indianapolis (IN); Remote; USD 140,000 - 210,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client. You will be responsible for end-to-end statistical programming, including SDTM/ADaM development, defining specifications, and overseeing CROs to ensure timely, high-quality data outputs.

You’ll drive regulatory submissions and support study reports with expert SAS/R skills. The role requires 7+ years in biostatistics programming, strong CDISC knowledge, and the ability to work independently while

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 CDISC SDTM/ADaM/Define.xml experience.
• Experience supporting regulatory submissions and FDA/ICH guidance.
• Ability to work independently and lead technical efforts.
• Strong written and verbal communication and leadership capabilities.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs for clinical development needs.
• Oversee CRO deliverables to meet timelines and quality expectations.
• Support clinical study reports, regulatory submissions, DSURs and analyses.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs and macros.
• Contribute to CRF/edit check specifications and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors and partners to meet project goals.

Skills

CDISC standards & data

Independent work

Leadership

Communication

Regulatory submissions experience

Biotech/Pharma experience

SAS programming expertise

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client. You will be responsible for end-to-end statistical programming, including SDTM/ADaM development, defining specifications, and overseeing CROs to ensure timely, high-quality data outputs.

You’ll drive regulatory submissions and support study reports with expert SAS/R skills. The role requires 7+ years in biostatistics programming, strong CDISC knowledge, and the ability to work independently while