Senior Statistical Programmer (SAS/R) - Remote Lead

Placements24; South Africa; Remote; ZAR 2,080,000 - 2,995,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will lead SAS programming for SDTM/ADaM, define.xml, and complex outputs, while overseeing CRO deliverables and contributing to regulatory submissions. Strong communication and leadership are essential.

Ideal candidates have 7+ years in biotech/pharma biometrics, proficiency in SAS and R, CDISC standards, and experience with FDA/ICH guidelines.

Qualifications

• Bachelor's degree in CS/Data Science/Math/Stats.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development.
• Exceptional SAS programming skills in clinical development.
• CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation experience.
• Regulatory submission experience and CRO oversight.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and Define.xml for studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of CSR, regulatory submissions, DSUR and analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools and macros.
• Develop CRF/edit check specs and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with CROs, vendors and partners to meet goals.
• Review SOPs and work instructions for programming practices.

Skills

SAS programming

Statistical programming

Leadership

Communication skills

Independent work

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

R

Python

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will lead SAS programming for SDTM/ADaM, define.xml, and complex outputs, while overseeing CRO deliverables and contributing to regulatory submissions. Strong communication and leadership are essential.

Ideal candidates have 7+ years in biotech/pharma biometrics, proficiency in SAS and R, CDISC standards, and experience with FDA/ICH guidelines.