Senior Principal Statistical Programmer (SAS + R) - Remote

Datafin It Recruitment; Wes-Kaap; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Datafin It Recruitment seeks a Senior/Principal Statistical Programmer for a remote sponsor-dedicated role with a leading pharmaceutical client. You will implement SDTM/ADaM specifications, generate datasets and reports, and support regulatory submissions in a fast-paced Biostatistics environment.

The position requires 7+ years in clinical programming, expert SAS skills, knowledge of CDISC standards, and the ability to lead CROs and collaborate across teams while delivering high-quality results.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma clinical development.
• Expert SAS programming in a clinical development environment.
• Extensive CDISC SDTM/ADaM, Define.xml experience and regulatory submissions.
• Strong communication, independence, and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specs, 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/R programming results for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and DSURs.
• Adhere to FDA regulations, GCP and electronic submission guidelines.
• Contribute to standards for programming tools, outputs and macros.
• Collaborate with CROs, vendors and clinical partners to meet project goals.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

R programming

Regulatory submissions

FDA regulations

Lead CROs

Independent work

Leadership

Education

Bachelor's degree in CS/Data Science/Math/Stats

Tools

R

Unix/Linux

Git

SAS

Job description

Datafin It Recruitment seeks a Senior/Principal Statistical Programmer for a remote sponsor-dedicated role with a leading pharmaceutical client. You will implement SDTM/ADaM specifications, generate datasets and reports, and support regulatory submissions in a fast-paced Biostatistics environment.

The position requires 7+ years in clinical programming, expert SAS skills, knowledge of CDISC standards, and the ability to lead CROs and collaborate across teams while delivering high-quality results.