Remote Principal Statistical Programmer - SAS/SDTM

Cytel; Denver (CO); Remoto; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality programming for clinical trials and regulatory submissions.

You will lead SDTM/ADaM development, oversee CROs, and ensure FDA/ICH compliance, with autonomy and strong communication.

Requires a bachelor degree and 7+ years; expertise in SAS, CDISC, and cross-functional collaboration.

Competenze

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills for clinical development.
• Extensive CDISC (SDTM/ADaM/Define.xml) and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently; strong written and verbal communication and leadership.

Mansioni

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and Define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical development needs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of CSRs, regulatory submissions, DSURs and exploratory analyses.
• Contribute to standards for programming tools, outputs and macros.
• Collaborate with CROs, vendors and clinical partners to meet timelines.
• Provide review/author SOPs and work instructions for programming practices.

Conoscenze

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent worker

Leadership

Clinical data systems

Formazione

Bachelor's degree

Strumenti

R

Python

Unix/Linux

Git

Descrizione del lavoro

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality programming for clinical trials and regulatory submissions.

You will lead SDTM/ADaM development, oversee CROs, and ensure FDA/ICH compliance, with autonomy and strong communication.

Requires a bachelor degree and 7+ years; expertise in SAS, CDISC, and cross-functional collaboration.