Statistical Programmer (m/f/d)
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft
Dresden, Saxony, Germany
Information Technology, Analyst, Science / R&D / Research
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
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
- 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
About the company
Company website•Pharmaceutical Manufacturing
DEDICATED TO INNOVATIONS IN MEDICINE
ABX-CRO is an independent international Contract Research Organization, providing standard and specialised phase I - III clinical trial services with emphasis on oncology and molecular imaging.
TURNING IDEAS INTO PRODUCTS
While providing close assistance to our customers and partners in pharmacy and science industries, we also apply our expertise in the engineering of medical software products to support diagnostic as well as therapeutic innovation in molecular imaging and related therapies.
WORLDWIDE COVERAGE
Privately founded in 2002, ABX-CRO is based in Dresden, Germany. Our global clinical coverage is backed up by local offices in the EU, Australia and South Africa as well as a network of freelance experts, whereas our specialist radiopharmacy services and the physics department operate centrally from Germany.
THE ABX-CRO FAMILY
Our interdisciplinary team is formed by experts in chemistry, medicinal physics, biology and medicine as well as experienced project managers, clinical trial assistants, research administrators, medical writers and software developers. While their professional backgrounds are as diverse as their origin nationalities and ethnies are, they all share a spirit of combatting human diseases by a believe in the power of innovation. So no matter whether you're interested in a long-term professional development, or your comprehensive professional experience is seeking new horizons: We would be pleased to get in touch with you.
ABX-CRO advanced pharmaceutical services
Forschungsgesellschaft mbH
Schössergasse 19
D-01067 Dresden · Germany
Telephone: +49 351 21444-0
Telefax: +49 351 21444-15
Dr. Andreas Kluge
General Manager
E-Mail: info[at]abx-cro.com
Amtsgericht Dresden HRB21253
USt-ID DE 813 528 365