Senior Statistical Programmer (SAS / R)

Clymb Clinical LLC; Bloemfontein; On-site; ZAR 600,000 - 900,000; Full time

Job summary

Clymb Clinical LLC is seeking a Sr. Statistical Programmer to join our on-site team in Bloemfontein, South Africa. The role focuses on developing and validating SAS/R programs to produce CDISC SDTM and ADaM datasets and TFLs in alignment with the SAP.

Responsibilities include validating programs, creating submission documents, and contributing to automation projects using CDISC standards. A Master's or equivalent with relevant experience is required, with strong organizational and communication

Qualifications

• Master's degree or equivalent with relevant formal qualifications and 3+ years SAS/R programming; or Bachelor's with 5+ years SAS/R experience.
• Proficiency in SAS and R programming with CDISC standards knowledge.
• Strong organizational, interpersonal, leadership, and communication skills.

Responsibilities

• Develop and validate programming specifications and programs for CDISC SDTM and ADaM datasets.
• Create and validate TFLs (tables, figures, listings) per the analysis plan.
• Review study documents (protocol, SAP, CRF) and ensure compliance with SOPs.
• Develop and review CDISC SDTM/ADaM mappings and submission paperwork (define.xml, annotated CRF).
• Produce efficient code and automated utilities to streamline results creation.

Skills

SAS programming

R programming

CDISC standards

Communication skills

Leadership

Project management

Education

Master's degree or equivalent

Bachelor's degree with 5+ years SAS/R experience

Tools

SAS

R

Job description

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.

Primary job role

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.

Responsibilities

• 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.

Requirements

• 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.

Not required, but a strong plus

• 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.