Senior Statistical Programmer; SAS​/R

Our group is growing rapidly, and we are currently seeking a full-time, Sr. Statistical Programmer to join our team on-site in Bloemfontein, South Africa.

Applicants must reside within a commutable distance of the Bloemfontein site.

This position is direct hire, no third parties please.

The Sr. Statistical Programmer will develop and validate technical programming specifications and programs, and generate SDTM and ADaM datasets, tables, figures, and listings. Furthermore, the role will include contributions to innovative TFL automation projects utilizing CDISC Standards like ARS, USDM, Analysis Concepts, etc.

• Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
• Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
• Execution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
• Development and review CDISC SDTM and ADaM mapping specifications.
• Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
• Review datasets for any pending compliance issues and meticulously document identified issues.
• Generation and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.
• Generation of utility macros and efficient code writing to streamline programming processes.
• Communicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.
• Ensure compliance with applicable SOPs and guidelines throughout all programming activities.
• Contribute to software development projects aimed at automating the end-to-end results creation process utilizing CDISC Standards (SAP to CSR).
• Adherence to Clymb and/or client's Policies and Procedures.

• Master's degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 3 years of SAS/R programming experience. Alternatively, a Bachelor's degree with at least 5 years of SAS/R programming experience.
• Proficiency in both SAS and R programming.
• A solid understanding of and familiarity with CDISC standards.
• Strong organizational, interpersonal, leadership, and communication skills.
• Ability to autonomously manage multiple tasks and projects.

• Familiarity with CDISC 360i and the Analysis Results Standard (ARS)
• Previous involvement or experience in software development
• Previous experience with automation projects (e.g. macro automation, RPA, etc.)
• Proficiency in using AI tools responsibly to enhance efficiency

We partner with pharma, biotech, CROs, and technology vendors on platform access, outsourcing, and FSP delivery.