Senior Statistical Programmer — Remote, SAS + R, CDISC

Placements24; East London; Remote; ZAR 900,000 - 1,400,000; Full time

Job summary

Placements24 is seeking a Senior/Principal Statistical Programmer (Remote) to deliver SDTM/ADaM, define.xml, and complex analyses for one or more global pharma clients. You will develop SAS programs, oversee CROs, and support regulatory submissions in a fast-paced environment.

The role requires 7+ years of relevant experience, strong CDISC knowledge, and the ability to work independently with high-quality communication. Remote role with international collaboration and sponsor support.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development or similar.
• Exceptional SAS programming skills and expertise in clinical development environment.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently and lead.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM/ADaM specs, datasets, define.xml, and reviewer’s guides for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality programming outputs and validate SAS/R programs for clinical programs.
• Oversee CRO programming deliverables to meet timelines.
• Support CSR preparation, regulatory submissions, publications, DSURs, and exploratory analyses.
• Adhere to FDA regulations and GCP for electronic submissions.
• Contribute to standards, tools, outputs, and macros documentation.
• Develop CRF edit checks and data validation plans.
• Collaborate with internal/external partners to meet project goals.
• Draft SOPs/Work Instructions for statistical programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

FDA/ICH regulations

Regulatory submissions

Leadership

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Placements24 is seeking a Senior/Principal Statistical Programmer (Remote) to deliver SDTM/ADaM, define.xml, and complex analyses for one or more global pharma clients. You will develop SAS programs, oversee CROs, and support regulatory submissions in a fast-paced environment.

The role requires 7+ years of relevant experience, strong CDISC knowledge, and the ability to work independently with high-quality communication. Remote role with international collaboration and sponsor support.