01Overview
Job Description:
Minimum Requirements
Bachelors 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 environment with clinical team members.
Preferred Requirments
Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical developmentKnowledge of the drug development process, clinical trial methodology, statistics .
