Principal Statistical Programmer (Remote) - Biotech/Pharma

London Early Years Foundation (Leyf); East London; Remote; ZAR 1,990,000 - 2,985,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-driven program within a pharmaceutical client. You will deliver SDTM/ADaM specs, SAS and R programs, and complex listings with consistent, high-quality results. Independent work and leadership are essential for success.

The role requires 7+ years in biotech/pharma, expertise in CDISC standards, and experience with regulatory submissions. Excellent communication skills and teamwork are valued.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in biotech/pharma clinical development.
• Excellent SAS programming skills and experience in clinical programming.
• Extensive CDISC SDTM/ADaM/Define.xml knowledge and regulatory submission experience.
• Experience interacting with FDA or global regulatory authorities.

Responsibilities

• Generate SDTM, ADaM specs, datasets and Define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs for clinical programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports and regulatory submissions.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to creation and validation of programming standards and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review external data transfer specifications and collaborate with vendors.
• Provide SOPs and work instructions for programming practices.

Skills

Communication skills

Leadership

Independent worker

Education

Bachelor's degree in CS/Statistics

Tools

SAS

R

Python

Define.xml

SDTM

ADaM

CDISC

FDA/ICH

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-driven program within a pharmaceutical client. You will deliver SDTM/ADaM specs, SAS and R programs, and complex listings with consistent, high-quality results. Independent work and leadership are essential for success.

The role requires 7+ years in biotech/pharma, expertise in CDISC standards, and experience with regulatory submissions. Excellent communication skills and teamwork are valued.