AbbVie Statistical Programmer / Analyst (m/f) in Palatinate, Germany
The Statistical Programming group is a part of Data and Statistical Sciences (DSS) and is responsible for providing statistical programming services to the Global Pharmaceutical Research and Development division (GPRD). These services are supplied in the context of a cooperative and project-oriented effort with the Global Project Teams (GPTs) and Product Safety teams (PSTs) in the summarization and reporting of data from clinical trials. These services also include the summarization of aggregate data and creation of submission documents to be provided to regulatory agencies.
Key Responsibilities: Provide statistical programming support for the reporting of clinical trial results for multiple clinical projects or therapeutic areas.
- Develop and document SAS programs used in the production of statistical outputs.
o Generation of specifications and development of programs for analysis datasets o Development of programs used to generate listings, tables, graphs and narratives o Create peer review programs including generation of validation documentation o Design of integrated databases and development of mapping specifications for integrated datasets
- Review output to ensure internal consistency with other output for the activity (CSR, ISS, ISE, …).
- Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities.
- Review case report forms (CRFs) and database definitions.
- Develop database checks for routine situations.
- Work collaboratively with Data Analysts, Data Warehouse Analysts and Statisticians to develop quality CRFs, databases, reports, publications and regulatory submissions.
- Learn and maintain expertise in the use of the SAS Macros developed for the Statistical Programmers.
- Clearly communicate fundamental statistical programming concepts to Statistical Programmers and Statisticians.
- Coordinate the statistical programming activities for up to 2 early stage clinical projects in the same therapeutic area.
- MS or BS in Statistics, Computer Science or a related field.
- Statistical programming experience related to clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience is of advantage.
- Thorough understanding of ICH Guidelines and relevant regulatory requirements.
- Knowledge of industry data standards (e.g. CDISC SDTM and ADaM).
- Competent in the use of the statistical software package SAS (BASE, GRAPH, MACRO and STAT).
- Knowledge of "R" is of advantage.
Written and spoken fluency in English.
We are looking forward for your application. Please give us information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: Germany-Rhinland-Palatinate-Ludwigshafen
Organization: Research & Development
Shift: Not required
Travel: Yes, 10 % of the Time
Req ID: 1607543