Principal Statistical Programmer — Remote

Placements24; Upington; Remote; ZAR 1,498,000 - 2,496,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a pharmaceutical client. You will independently lead programming activities, produce SDTM/ADaM specifications, and supervise CROs to ensure high-quality data deliveries for clinical trials.

The role requires 7+ years of experience, exceptional SAS skills, CDISC expertise, and involvement in regulatory submissions. Strong communication and leadership are essential for success.

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.
• Exceptional SAS programming skills with experience in clinical development environments.
• Extensive applied experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, and regulatory guidelines (FDA/ICH).
• Experience supporting regulatory submissions and interactions with FDA/global regulatory authorities.
• Ability to work independently and lead teams with strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs; collaborate with statisticians on descriptive and inferential statistics.
• Deliver high-quality SAS/R programming outputs and maintain reproducible code for programming standards.
• Oversee CROs' statistical programming deliverables to meet timelines and quality requirements.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
• Ensure compliance with FDA regulations and GCP in reporting of clinical trial data.
• Contribute to development and maintenance of programming tools, outputs, and macros; create data validation plans and CRFs.

Skills

SAS programming

R programming

Statistical programming

CDISC SDTM/ADaM

Data analysis

Leadership

Communication skills

Education

Bachelor's degree in Computer Science, Data Science, Mathematics or Statistics

Tools

SAS

R

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a pharmaceutical client. You will independently lead programming activities, produce SDTM/ADaM specifications, and supervise CROs to ensure high-quality data deliveries for clinical trials.

The role requires 7+ years of experience, exceptional SAS skills, CDISC expertise, and involvement in regulatory submissions. Strong communication and leadership are essential for success.