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001 – Senior/Principal Statistical Programmer
An international and growing Pharmaceutical company at is now looking for an experienced Statistical Programmer (M / F) in Germany. You will be part of the team in Programming,working on innovative projects and will get the chance to specialize on different areas. The working environment is really friendly and international.
As a Senior/Principal Statistical Programmer, your task will :
- Develop and maintain internal CDISC standards and supervise service providers accordingly
- 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
- Support data managers in performing user acceptance testing (UAT) required for EDC and other IT applications
The Job position requires following skills and experience:
- Bachelor or Master in Science and Statistics, Computer Science or a relevant field is desirable.
- Demonstrated professional experience as a Lead SAS Programmer, developed in a pharmaceutical company, CRO or Biotech / Biopharma
- Demonstrated experience in creating macro, TFL production and all tasks related to the statistical programming
- No need to talk German but strong motivation to learn the language
- Experience with CDISC / ADaM-SDTM
- Understanding of database structures and complex data structures
- Excellent communication and presentation of results skills
- Ability to meet strict deadlines and to work as part of an international team
If your experience and skills matches the job position, please send us your profiles @ jayaprakash@aadyaconsultancy.com .
We will contact you soon for further discussion.
002 – Manager (m / f) Data Management and Statistical Programming
Your tasks:
- Planning and implementation of the executed internal and external data management
- Verification of data quality of clinical trials phase I-IV and of non-interventional studies (NIS)
- Production, ensuring access control and routing of study data in compliance with the regulatory requirements
- Ensuring high data quality of clinical trials in the context of quality control (QC)
- Performing statistical programming for data control and internal data analysis
- Responsibility for compliance with external and internal regulations and standards (particularly ICH GCP and Internal SOPs)
- Ensuring data transfers within the agreed data format (SDTM, ADaM)
- Establishment of clinical data standards in CDISC format
Your profile:
- Successful degree in natural sciences, preferably the direction of medical / life science documentation, statistics, or equivalent qualification
- At least 5 years experience in the pharmaceutical industry / CRO, preferably in the field of Data Management
- Very good programming skills in SAS
- Profound knowledge in CDISC (SDTM and ADaM) and in all the relevant regulatory guidelines including ICH / GCP
- Fluent in English (also in the medical-scientific field)
- Excellent communication and coordination skills
If your experience and skills matches the job position, please send us your profiles @ jayaprakash@aadyaconsultancy.com .
We will contact you soon for further discussion.