Principal Statistical Programmer – Remote (SAS + R)

Morgan Industries Limited; South Africa; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work within a sponsor-dedicated team in clinical development.

You will implement reporting and analysis activities for the Sponsor trials and oversee CRO programmers to ensure timely, high-quality outputs. The role requires 7+ years in statistical programming, expertise in SDTM/ADaM, CDISC, and strong independent working; responsibilities include creating SDTM/ADaM specs, define.xml, complex listings and regulatory

Qualifications

• Bachelor's degree in a quantitative field; 7+ years in statistical programming for biotech/pharma.
• Exceptional SAS programming skills and experience with SDTM/ADaM and Define.xml.
• Experience supporting regulatory submissions and FDA/ICH guidelines.
• Ability to work independently with strong communication and leadership.
• Experience supervising CROs and ensuring timely, high-quality deliverables.
• Familiarity with other programming languages (R, Python) is a plus.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and complex graphs.
• Deliver high-quality statistical programming results with SAS and/or R.
• Oversee CROs' statistical programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, and DSURs.
• Adhere to FDA regulations and good clinical practice for data reporting.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review/author data transfer specifications for external vendors.
• Collaborate with internal/external partners to meet project goals and timelines.
• Create SOPs and Work Instructions related to statistical programming practices.

Skills

SAS programming

Statistical programming

CDISC standards

Leadership

Communication skills

Education

Bachelor's degree in computer science / data science / mathematics / statistics

Tools

R

SAS

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work within a sponsor-dedicated team in clinical development.

You will implement reporting and analysis activities for the Sponsor trials and oversee CRO programmers to ensure timely, high-quality outputs. The role requires 7+ years in statistical programming, expertise in SDTM/ADaM, CDISC, and strong independent working; responsibilities include creating SDTM/ADaM specs, define.xml, complex listings and regulatory