Job
- Level
- Senior
- Job Feld
- Data
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
- Ort
- Oberwöhr
- Arbeitsmodell
- Hybrid, Onsite
Job Technologien
Deine Rolle im Team
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
- Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures ( TLFs)
- Production and QC / validation programming
- Generating complex ad-hoc reports utilizing raw data
- Applying strong understanding/experience of Efficacy analysis
- Creating and reviewing submission documents and eCRTs
- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
- Performing lead duties when called upon
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
Unsere Erwartungen an dich
Ausbildung
- Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
- At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
Qualifikationen
- Strong SAS data manipulation, analysis and reporting skills.
- Strong QC / validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Erfahrung
- Study lead experience, preferably juggling multiple projects simultaneously preferred.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
- Submissions experience utilizing define.xml and other submission documents.
- Experience supporting Rare diseases and Gastro Intestinal studies would be a plus.
Job Standorte
Standort Oberwöhr
Bayern
Deutschland
Das ist dein Arbeitgeber
Cytel
We provide unrivaled biostatistics and operations research knowledge to our customers. Our knowledge is available in the form of both software and services. This knowledge, supported by our trial implementation capabilities, is what makes us different. We are leaders in the design and implementation of adaptive clinical trials.
Description
- Gründungsjahr
- 1987
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Hybrid, Onsite
- Branche
- Pharma, Chemie, Biotech
Senior Developer Data
- Ort
- Oberwöhr
- Arbeitsmodell
- Hybrid, Onsite
