01Requirements
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 valuable 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 development
Knowledge of the drug development process, clinical trial methodology, statistics .
