Statistical Programmer

Looking for a new challenge?

Do you want to actively contribute to the advancement of a future-oriented healthcare system? Than join our team in Cape Town Area as

Statistical Programmer (m/f/d)
Full time / Permanent / ABX CRO Location Cape Town Area, South Africa

ABX-CRO is a privately owned, internationally operating, clinical and pre-clinical contract research organisation. Since 2002 we provide a wide variety of services to customers in pharmaceutical, biotechnology, medical device and medical supply industries, ranging from pre-clinical proof of-concept studies to planning, conducting and analysis of clinical trials on innovative treatments for patients with unmet medical needs. Our long-term experience with molecular imaging and radiology for development of both diagnostics and therapeutics has created an important company focus, particularly in oncological and neurological disease areas. Not only do we serve this purpose through clinical trials, but we also develop innovative software for radio-therapeutical practice and research.

We are looking for an experienced
Statistical Programmer (SDTM/ADaM/TFLs)
to join our Cape Town team.

Your Responsibilities

• Review protocol, SAP and TFL shells from a programming perspective
• Develop SDTM and ADaM specifications, annotate CRF, and contribute to the development of company and client standards
• Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs
• Plan, execute programming activities on a study as part of the stats programming team
• Produce and reviewers guides for SDTM and ADaM
• Program TFLs as per shells
• Perform quality control reviews of outsourced SDTM, ADaM deliverables
• Mentor less-experienced team members in best practices around SDTM, ADaM and TFLs
• Contribute to the development of department SOPs
• Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
• Interacting with data managers, clinical programmers, statisticians, medical writers, external vendors.

Your Qualifications

• University degree in Mathematics, Computer Science, Life Science, Medical Informatics or equivalent qualification or an equivalent professional experience in statistical programming for drug development
• 5 + years' experience as a statistical programmer working on complex studies in the pharmaceutical / CRO industry
• Excellent knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs
• Experience with running Pinnacle 21 to validate SDTM/ADaM datasets
• Experience in creating RG and
• Good knowledge with building, mapping, annotating, QC'ing, and understanding flow of SDTM data and ADaM, including , Reviewer's Guide and submission standards
• Oncology experience an advantage
• Business fluency in English – both verbal and written – is a must
• Attention to detail and problem-solving skills
• Good time management and documentation skills
• Respoonsible, highly motivated team player who can communicate within a team and are confident with site staff and Sponsor

What We Have To Offer You

• A responsible position in an innovative, international environment
• Opportunity to develop within a growing quality and compliance team
• Competitive compensation based on qualifications and experience
• Internal and external training and career development programs

Deine Benefits Bei ABX-CRO
Flexible working hours

Hybrid work options

Apply now

Please send your application as a single PDF document, including your salary expectations, to -

Your Point Of Contact
Laurie Ben-yair

Director of Data Management