Statistical Programmer (m/f/d)

Looking for a new challenge?
Do you want to actively contribute to the advancement of a future-oriented healthcare system?
Then join our Data Management team as

Statistical Programmer (m/f/d)

Full-time · Permanent 

ABX-CRO Company Location Cape Town Area, South Africa

About us

 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 Tasks & 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 define.xml 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 define.xml

    • Good knowledge with building, mapping, annotating, QC’ing, and understanding flow of SDTM data and ADaM, including define.xml, 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

    • Responsible, highly motivated team player who can communicate within a team and are confident with site staff and Sponsor
      

Your Point of Contact

Laure Ben-yair
Director of Data Management