Senior Principal Statistical Programmer (Remote, SAS/R)

Placements24; Rustenburg; Remote; ZAR 1,985,000 - 2,977,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work within a sponsor-dedicated role and deliver high-quality clinical programming for multiple studies. You will generate SDTM/ADaM specifications, develop SAS and R programs, and oversee CROs to ensure timely, accurate data outputs and regulatory submissions.

The role requires 7+ years of experience, strong SAS expertise, and deep knowledge of CDISC standards and FDA regulation, with the ability to work independently and

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills in clinical development environment.
• Extensive CDISC SDTM/ADaM/Define.xml experience and FDA/ICH knowledge.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently and lead teams.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality programming results and maintain SAS/R programs for clinical programs.
• Oversee CROs' programming deliverables to meet timelines and quality.
• Assist in preparation of clinical study reports, regulatory submissions, and publications.
• Ensure compliance with FDA regulations and regulatory guidelines.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml experience

FDA/ICH regulation

Leadership

Excellent communication

Education

Bachelor's degree in CS/DS/Math/Stats

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work within a sponsor-dedicated role and deliver high-quality clinical programming for multiple studies. You will generate SDTM/ADaM specifications, develop SAS and R programs, and oversee CROs to ensure timely, accurate data outputs and regulatory submissions.

The role requires 7+ years of experience, strong SAS expertise, and deep knowledge of CDISC standards and FDA regulation, with the ability to work independently and