Beschreibung
Job Description:- The Statistical Programmer is responsible for the statistical programming of preclinical and clinical trials as well as for ISS/ISE in collaboration with the biostatisticians and data management.
- Statistical programming of tables, listings and figures for preclinical and clinical studies
- Develop programming specifications for analysis datasets, pooled datasets and deliverables in consultation with the statistician
- Support quality control and quality checks of deliverables
- Support of biostatisticians in SAP development
- Statistical programming of ISS/ISE and for requests from authorities
- Develop and maintain internal CDISC standards and supervise service providers accordingly
- Support data managers in performing user acceptance testing (UAT) required for EDC and other IT applications and ensure that the UAT is performed to a satisfactory quality level
Requirements:
- At least 5 years of experience in a statistical programming role supporting clinical trials in the pharmaceutical industry
- Profound knowledge in CDISC standards (SDTM, ADaM, Define.XML)
- Experience in CDISC standards
- Intermediate to expert knowledge of / experience with SAS software (including SAS macro language)
- Ability to coordinate programming work across a clinical study
- Experience in setup of clinical databases and (e)CRF design
- Good understanding of global clinical trial practices, procedures and methodologies
- Good team player. Good business ethics
- Very good English (oral and written), German of advantage
Bitte lassen Sie mir Ihren CV im Word-Format zukommen, falls Sie Interesse an der Position haben. Gerne können wir telefonisch alle weiteren Details klären.
Ich freue mich auf Ihre Rückmeldung!
Viele Grüße aus München,
Carla Störzer