- Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
- A programming experience in industry recommended.
- For US positions: US military experience will be considered towards industry experience.
- Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.
- Understanding of clinical data structure (e.g. CDISC standards) and relational database.
- Demonstrated skills in using software tools and applications, e.g., MS office, XML.
- Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
- Demonstrated ability in providing outputs to meet downstream requirements, e.g.,
ADaM,
Data Definition Table, e-submission.
- Have good understanding of regulatory, industry, and technology standards and requirements.
- Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
- Demonstrated ability to work in a team setting with clinical team members.
Preferred Requirments
- Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development
- Knowledge of the drug development process, clinical trial methodology, statistics