Senior Principal Statistical Programmer - SAS + R (Remote)

Mediclinic International; Welkom; Remote; ZAR 1,997,000 - 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, develop SDTM/ADaM artifacts, and supervise CRO deliverables to ensure high-quality data outputs for regulatory submissions. You will contribute to study reports and regulatory interactions, applying CDISC standards and FDA/ICH guidelines while collaborating with cross-functional teams.

Qualifications

• At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and experience developing and implementing statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with the FDA or global regulatory authorities.
• Must be able to work independently.
• Outstanding communication skills (written and verbal) and strong leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical development needs.
• Oversee CRO statistical programming deliverables for multiple studies to ensure quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
• Understand and follow FDA regulations affecting reporting of clinical trial data.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Communication

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Unix/Linux

Git

Markdown

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, develop SDTM/ADaM artifacts, and supervise CRO deliverables to ensure high-quality data outputs for regulatory submissions. You will contribute to study reports and regulatory interactions, applying CDISC standards and FDA/ICH guidelines while collaborating with cross-functional teams.