Principal Statistical Programmer (SAS + R) — Remote

Smartrecruiters, Inc.; South Africa; Remote; ZAR 1,983,000 - 2,974,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R for a fully remote role, embedded with a pharmaceutical client. Lead development and validation of SDTM/ADaM datasets, listings, tables, and graphs, while ensuring quality and regulatory conformity.

You will oversee CRO work, contribute to study reports and submissions, and advance standards for programming practices in a fast-paced biostatistics team.

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 Team or similar.
• Exceptional SAS programming skills and expertise in clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions, interacting with FDA/global regulatory authorities.
• Ability to work independently and lead.
• Outstanding communication and leadership skills.
• Nice to have pharmacokinetic data experience; knowledge of R, Python, Java, Shiny, Unix/Linux and git.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs with descriptive and inferential statistics.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs for clinical programs.
• Oversee CROs' programming deliverables to meet timelines and quality standards.
• Assist in preparing clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
• Ensure compliance with FDA regulations and GxP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Assist in developing CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project goals and deadlines.
• Contribute to SOPs and Work Instructions for programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Statistical programming

Regulatory submissions

Leadership

Communication

Independent work

R programming

Education

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

Tools

R

Python

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R for a fully remote role, embedded with a pharmaceutical client. Lead development and validation of SDTM/ADaM datasets, listings, tables, and graphs, while ensuring quality and regulatory conformity.

You will oversee CRO work, contribute to study reports and submissions, and advance standards for programming practices in a fast-paced biostatistics team.